Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05131477
Registration number
NCT05131477
Ethics application status
Date submitted
11/11/2021
Date registered
23/11/2021
Date last updated
3/07/2025
Titles & IDs
Public title
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
Query!
Scientific title
A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis
Query!
Secondary ID [1]
0
0
2021-000725-28
Query!
Secondary ID [2]
0
0
KY1005-CT05/DRI17366
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
STREAM-AD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Eczema
0
0
Query!
Atopic Dermatitis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Placebo
Experimental: 250mg (500mg Loading Dose) KY1005 - Every 4 weeks
Experimental: 250mg (No Loading Dose) KY1005 - Every 4 weeks
Experimental: 125mg KY1005 - Every 4 weeks
Experimental: 62.5mg KY1005 - Every 4 weeks
Placebo comparator: Placebo - Every 4 weeks
Treatment: Drugs: Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
Query!
Assessment method [1]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [1]
0
0
Baseline to week 16
Query!
Secondary outcome [1]
0
0
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)
Query!
Assessment method [1]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [1]
0
0
Baseline to week 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Query!
Assessment method [2]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [2]
0
0
Baseline to week 16 and week 24
Query!
Secondary outcome [3]
0
0
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline = 2 Points (Part 1)
Query!
Assessment method [3]
0
0
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
Query!
Timepoint [3]
0
0
Baseline to week 16 and week 24
Query!
Secondary outcome [4]
0
0
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) = 4 With a Baseline Pruritus of = 4 From Baseline (Part 1)
Query!
Assessment method [4]
0
0
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Query!
Timepoint [4]
0
0
Baseline to week 16 and week 24
Query!
Secondary outcome [5]
0
0
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) = 4 With a Baseline Pruritus of = 4 From Baseline (Part 2)
Query!
Assessment method [5]
0
0
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Query!
Timepoint [5]
0
0
Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Query!
Secondary outcome [6]
0
0
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Query!
Assessment method [6]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [6]
0
0
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Query!
Secondary outcome [7]
0
0
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Query!
Assessment method [7]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [7]
0
0
Baseline to weeks 2,4, 8,12,16, 20 and 24
Query!
Secondary outcome [8]
0
0
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Query!
Assessment method [8]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [8]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Query!
Secondary outcome [9]
0
0
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Query!
Assessment method [9]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [9]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Query!
Secondary outcome [10]
0
0
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Query!
Assessment method [10]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [10]
0
0
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Query!
Secondary outcome [11]
0
0
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Query!
Assessment method [11]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [11]
0
0
Baseline at weeks 2, 4, 8, 12, 16, 20 and 24
Query!
Secondary outcome [12]
0
0
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Query!
Assessment method [12]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [12]
0
0
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Query!
Secondary outcome [13]
0
0
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Query!
Assessment method [13]
0
0
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Query!
Timepoint [13]
0
0
Baseline to weeks 2, 4, 8, 12, 16, 20 and 24
Query!
Secondary outcome [14]
0
0
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Query!
Assessment method [14]
0
0
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Query!
Timepoint [14]
0
0
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Query!
Secondary outcome [15]
0
0
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Query!
Assessment method [15]
0
0
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Query!
Timepoint [15]
0
0
Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52
Query!
Secondary outcome [16]
0
0
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of = 2 Points (Part 1)
Query!
Assessment method [16]
0
0
The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Query!
Timepoint [16]
0
0
Baseline to weeks 2, 4, 8,12,16,20 & 24
Query!
Secondary outcome [17]
0
0
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Query!
Assessment method [17]
0
0
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Query!
Timepoint [17]
0
0
Baseline to weeks 4, 8, 12, 16, 20 & 24
Query!
Secondary outcome [18]
0
0
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Query!
Assessment method [18]
0
0
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Query!
Timepoint [18]
0
0
Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52
Query!
Secondary outcome [19]
0
0
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Query!
Assessment method [19]
0
0
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Query!
Timepoint [19]
0
0
Baseline to weeks 4, 8, 12, 16, 20, & 24
Query!
Secondary outcome [20]
0
0
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Query!
Assessment method [20]
0
0
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Query!
Timepoint [20]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Query!
Secondary outcome [21]
0
0
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Query!
Secondary outcome [22]
0
0
Absolute Change in Affected BSA From Baseline (Part 2)
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Query!
Secondary outcome [23]
0
0
Percentage Change in Affected BSA From Baseline (Part 1)
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Baseline to weeks 2, 4, 8, 12, 16, 20, & 24
Query!
Secondary outcome [24]
0
0
Percentage Change in Affected BSA From Baseline (Part 2)
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Query!
Secondary outcome [25]
0
0
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Query!
Assessment method [25]
0
0
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Query!
Timepoint [25]
0
0
Baseline to weeks 4, 8, 12, 16, 20, & 24
Query!
Secondary outcome [26]
0
0
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Query!
Assessment method [26]
0
0
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Query!
Timepoint [26]
0
0
Baseline to weeks 24, 32, 36, 40, 44, 48 & 52
Query!
Secondary outcome [27]
0
0
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Query!
Assessment method [27]
0
0
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Query!
Timepoint [27]
0
0
Baseline to weeks 4, 8, 12, 16, 20, & 24
Query!
Secondary outcome [28]
0
0
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Query!
Assessment method [28]
0
0
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Query!
Timepoint [28]
0
0
Baseline to weeks 24, 32, 36, 40. 44, 48, & 52
Query!
Secondary outcome [29]
0
0
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
Query!
Assessment method [29]
0
0
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Query!
Timepoint [29]
0
0
Baseline to weeks 2, 8, 16, 20, & 24
Query!
Secondary outcome [30]
0
0
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Query!
Assessment method [30]
0
0
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Query!
Timepoint [30]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Query!
Secondary outcome [31]
0
0
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
Query!
Assessment method [31]
0
0
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Query!
Timepoint [31]
0
0
Baseline to weeks 2, 8, 16, 20, & 24
Query!
Secondary outcome [32]
0
0
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Query!
Assessment method [32]
0
0
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Query!
Timepoint [32]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52
Query!
Secondary outcome [33]
0
0
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Query!
Assessment method [33]
0
0
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Query!
Timepoint [33]
0
0
Baseline to weeks 16, & 24
Query!
Secondary outcome [34]
0
0
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Query!
Assessment method [34]
0
0
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Query!
Timepoint [34]
0
0
Baseline to weeks 24, 36 & 52
Query!
Secondary outcome [35]
0
0
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Query!
Assessment method [35]
0
0
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Query!
Timepoint [35]
0
0
Baseline to weeks 16, & 24
Query!
Secondary outcome [36]
0
0
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Query!
Assessment method [36]
0
0
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Query!
Timepoint [36]
0
0
Baseline to weeks 24, 36 & 52
Query!
Secondary outcome [37]
0
0
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Query!
Assessment method [37]
0
0
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Query!
Timepoint [37]
0
0
Baseline to weeks 8 16, 20, & 24
Query!
Secondary outcome [38]
0
0
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Query!
Assessment method [38]
0
0
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Query!
Timepoint [38]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Query!
Secondary outcome [39]
0
0
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Query!
Assessment method [39]
0
0
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Query!
Timepoint [39]
0
0
Baseline to weeks 8, 16, 20, & 24
Query!
Secondary outcome [40]
0
0
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Query!
Assessment method [40]
0
0
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Query!
Timepoint [40]
0
0
Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52
Query!
Secondary outcome [41]
0
0
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Query!
Assessment method [41]
0
0
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Query!
Timepoint [41]
0
0
Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Query!
Secondary outcome [42]
0
0
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Query!
Assessment method [42]
0
0
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Query!
Timepoint [42]
0
0
Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Query!
Secondary outcome [43]
0
0
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Query!
Assessment method [43]
0
0
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Query!
Timepoint [43]
0
0
Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24
Query!
Secondary outcome [44]
0
0
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Query!
Assessment method [44]
0
0
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Query!
Timepoint [44]
0
0
Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52
Query!
Secondary outcome [45]
0
0
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) = 3 With a Baseline Pruritus NRS = 3 From Baseline (Part 1)
Query!
Assessment method [45]
0
0
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Query!
Timepoint [45]
0
0
Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24
Query!
Secondary outcome [46]
0
0
Incidence Rate of Loss of EASI 50 (Part 2)
Query!
Assessment method [46]
0
0
The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Query!
Timepoint [46]
0
0
Week 24 to week 52
Query!
Secondary outcome [47]
0
0
Incidence Rate of Loss of EASI 75 (Part 2)
Query!
Assessment method [47]
0
0
The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Query!
Timepoint [47]
0
0
Week 24 to week 52
Query!
Secondary outcome [48]
0
0
Incidence Rate of Loss of IGA 0/1 (Part 2)
Query!
Assessment method [48]
0
0
The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Query!
Timepoint [48]
0
0
Week 24 to week 68
Query!
Secondary outcome [49]
0
0
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Query!
Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24
Query!
Secondary outcome [50]
0
0
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Query!
Assessment method [50]
0
0
Query!
Timepoint [50]
0
0
Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52
Query!
Secondary outcome [51]
0
0
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)
Query!
Assessment method [51]
0
0
Query!
Timepoint [51]
0
0
Baseline through week 24
Query!
Secondary outcome [52]
0
0
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)
Query!
Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
Week 24 through week 68
Query!
Secondary outcome [53]
0
0
Percentage of Participants With Treatment-emergent ADA (Part 1)
Query!
Assessment method [53]
0
0
Query!
Timepoint [53]
0
0
Baseline through week 24
Query!
Secondary outcome [54]
0
0
Percentage of Participants With Treatment-emergent ADA (Part 2)
Query!
Assessment method [54]
0
0
Query!
Timepoint [54]
0
0
Baseline through week 68
Query!
Eligibility
Key inclusion criteria
* Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.
* Eczema Area and Severity Index (EASI) of 12 or higher at the Screening Visit and 16 or higher at Baseline.
* Investigator's Global Assessment (IGA) Scale of 3 or 4 at Baseline.
* AD involvement of 10% or more of body surface area (BSA) at Baseline.
* Baseline worst/maximum pruritus Numeric Rating Scale (NRS) of =4.
* Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments.
* Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.
* Able to complete patient questionnaires.
* Able and willing to comply with requested study visits/telephone visits and procedures.
* Able and willing to provide written informed consent.
* For patients who decide to join the biopsy sub-study be able and willing to provide skin biopsies.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.
* Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Weight <40 kg or >150 kg at Baseline.
* Treatment with a live (attenuated) immunization within 12 weeks prior to Baseline.
* Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding.
* Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and cured for more than 3 years prior to Baseline; in situ cervical carcinoma that has been excised and cured).
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
* Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
* In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology or urinalysis tests at the Screening Visit.
* Concurrent participation in any other clinical study, including non-interventional studies.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
13/12/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/02/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
390
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Investigative Site Number 3002 - Carlton
Query!
Recruitment hospital [2]
0
0
Investigative Site Number: 3003 - East Melbourne
Query!
Recruitment hospital [3]
0
0
Investigational Site Number: 3001 - Parkville
Query!
Recruitment postcode(s) [1]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [2]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [3]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oregon
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
South Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Bulgaria
Query!
State/province [14]
0
0
Pleven
Query!
Country [15]
0
0
Bulgaria
Query!
State/province [15]
0
0
Sofia
Query!
Country [16]
0
0
Bulgaria
Query!
State/province [16]
0
0
Stara Zagora
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Ontario
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Jihomoravský Kraj
Query!
Country [19]
0
0
Czechia
Query!
State/province [19]
0
0
Moravskoslezský Kraj
Query!
Country [20]
0
0
Czechia
Query!
State/province [20]
0
0
Praha, Hlavní Mesto
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Kutná Hora
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Ostrava
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Bayern
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Brandenburg
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Nordrhein-Westfalen
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Schleswig-Holstein
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Berlin
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Hamburg
Query!
Country [29]
0
0
Hungary
Query!
State/province [29]
0
0
Bács-Kiskun
Query!
Country [30]
0
0
Hungary
Query!
State/province [30]
0
0
Békés
Query!
Country [31]
0
0
Hungary
Query!
State/province [31]
0
0
Csongrád
Query!
Country [32]
0
0
Hungary
Query!
State/province [32]
0
0
Hajdú-Bihar
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Jász-Nagykun-Szolnok
Query!
Country [34]
0
0
Hungary
Query!
State/province [34]
0
0
Zala
Query!
Country [35]
0
0
Hungary
Query!
State/province [35]
0
0
Budapest
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Hokkaidô
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Kagosima
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Kanagawa
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Tiba
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Tokyo
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Kyoto-Shi
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Mibu-machi
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Sapporo
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Ôsaka
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Dolnoslaskie
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Lodzkie
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Lódzkie
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Malopolskie
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Mazowieckie
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Podkarpackie
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Podlaskie
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Pomorskie
Query!
Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Slaskie
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Zachodniopomorskie
Query!
Country [55]
0
0
Poland
Query!
State/province [55]
0
0
Bialystok
Query!
Country [56]
0
0
Poland
Query!
State/province [56]
0
0
Gdansk
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Krakow
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Lódz
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Valencia
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Alicante
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Córdoba
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Madrid
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Pontevedra
Query!
Country [64]
0
0
Taiwan
Query!
State/province [64]
0
0
Niao Song Qu
Query!
Country [65]
0
0
Taiwan
Query!
State/province [65]
0
0
Taichung
Query!
Country [66]
0
0
Taiwan
Query!
State/province [66]
0
0
Taipei
Query!
Country [67]
0
0
Taiwan
Query!
State/province [67]
0
0
Taoyuan
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
London
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Kymab Limited
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Sanofi
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05131477
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/77/NCT05131477/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/77/NCT05131477/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05131477
Download to PDF