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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
30/04/2024

Titles & IDs
Public title
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
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
Secondary ID [1] 0 0
2021-000725-28
Secondary ID [2] 0 0
KY1005-CT05/DRI17366
Universal Trial Number (UTN)
Trial acronym
STREAM-AD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 0 0
Atopic Dermatitis 0 0
Osteoarthritis 0 0
Post-traumatic Arthritis 0 0
Rheumatoid Arthritis 0 0
COVID-19 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Eye 0 0 0 0
Diseases / disorders of the eye
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KY1005
Treatment: Drugs - Placebo
Treatment: Surgery - Total Knee Arthroplasty
Treatment: Drugs - AZD8205
Treatment: Drugs - AZD8205 and AZD2936 (Rilvegostomig)
Treatment: Other - Spikogen/Covax-19

Experimental: KY1005 Dose Level 1 - Every 4 weeks

Experimental: KY1005 Dose Level 2 - Every 4 weeks

Experimental: KY1005 Dose Level 3 - Every 4 weeks

Experimental: KY1005 Dose Level 4 - Every 4 weeks

Placebo comparator: Placebo - Every 4 weeks

LEGION Porous CR with Hydroxyapatite - Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR with HA femoral component (min 117 subjects)

LEGION Porous CR without Hydroxyapatite - Patients who have already received or a due to receive a Porous Tibia + LEGION Porous CR without HA femoral component (min 117 subjects)

Experimental: Sub-Study 1 AZD8205 Monotherapy - Sub-Study 1 has two parts:

Part A : The aim is to determine the safety, tolerability, Recommended Phase 2 Dose(RP2D), and/or the Maximum Tolerated Dose (MTD) of AZD8205.

Part B: The aim of dose expansion is to evaluate anti-tumor activity of AZD8205 as monotherapy in select solid tumors.

Experimental: Sub Study 2: AZD8205 in combination with rilvegostomig - Sub-Study 2 has two parts:

Part A : Dose escalation to determine the safety, tolerability of AZD8205 + rilvegostomig Part B: Dose expansion to evaluate anti-tumor activity of AZD8205 + rilvegostomig in select solid tumors.

Active comparator: 3 week arm - Subjects will receive two doses of vaccine 3 weeks apart

Active comparator: 4 week arm - Subjects will receive two doses of vaccine 4 weeks apart

Active comparator: 5 week arm - Subjects will receive two doses of vaccine 5 weeks apart

Active comparator: 6 week arm - Subjects will receive two doses of vaccine 6 weeks apart


Treatment: Drugs: KY1005
Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Treatment: Surgery: Total Knee Arthroplasty
A surgical procedure to replace both the tibial and femoral articular surfaces with titanium prostheses.

Treatment: Drugs: AZD8205
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, and endometrial cancers

Treatment: Drugs: AZD8205 and AZD2936 (Rilvegostomig)
AZD8205 is an antibody drug conjugate that has the potential to treat a wide variety of solid tumors including but not limited to breast cancer, Biliary Tract Cancer, ovarian, and endometrial cancers.

Rilvegostomig is a bispecific antibody that specifically binds to human TIGIT and PD-1 and is a potential anticancer therapy in patients with advanced or metastatic solid tumors.

Treatment: Other: Spikogen/Covax-19
Spikogen/Covax-19 is a recombinant spike protein vaccine formulated with Advax-CpG55.2 adjuvant
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage change in EASI (Eczema Area and Severity Index) from Baseline
Timepoint [1] 0 0
Baseline to Day 113
Primary outcome [2] 0 0
Implant Survivorship (femoral and/or tibial component) 2 Years Post-Surgery
Timepoint [2] 0 0
2 years post-surgery
Primary outcome [3] 0 0
The number of patients with adverse events
Timepoint [3] 0 0
From time of Informed consent to 30 days post last dose (approximately 1 year).
Primary outcome [4] 0 0
The number of patients with serious adverse events
Timepoint [4] 0 0
From time of Informed consent to 30 days post last dose (approximately 1 year)
Primary outcome [5] 0 0
The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.
Timepoint [5] 0 0
From first dose of study treatment until the end of Cycle 1 (approximately 21 days).
Primary outcome [6] 0 0
The number of patients with changes from baseline laboratory findings, ECGs and vital signs
Timepoint [6] 0 0
From time of informed consent to 30 days post last dose (approximately 1 year)
Primary outcome [7] 0 0
Spike antibody immunogenicity
Timepoint [7] 0 0
3 weeks post second vaccine dose
Primary outcome [8] 0 0
Spike antibody seroconversion
Timepoint [8] 0 0
3 weeks post second vaccine dose
Primary outcome [9] 0 0
SARS-CoV-2 protection
Timepoint [9] 0 0
Accrual of events starting 2 weeks post second vaccine dose
Secondary outcome [1] 0 0
Incidence of treatment-emergent adverse event
Timepoint [1] 0 0
Baseline through Day 477
Secondary outcome [2] 0 0
Serum KY1005 concentration assessed throughout the study
Timepoint [2] 0 0
Baseline through Day 477
Secondary outcome [3] 0 0
Percentage change in EASI (Eczema Area and Severity Index) from baseline to Day 169
Timepoint [3] 0 0
Baseline to Day 169
Secondary outcome [4] 0 0
Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75)
Timepoint [4] 0 0
At Days 113 and 169
Secondary outcome [5] 0 0
Percentage of patients with a response of IGA (Investigator Global Assessment) 0 or 1 and a reduction from baseline = 2 points
Timepoint [5] 0 0
At Days 113 and 169
Secondary outcome [6] 0 0
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) = 4 with a baseline pruritus of = 4 from baseline
Timepoint [6] 0 0
Days 113 and 169
Secondary outcome [7] 0 0
Absolute change from Baseline in EASI (Eczema Area and Severity Index)
Timepoint [7] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [8] 0 0
Percentage change from Baseline in EASI (Eczema Area and Severity Index)
Timepoint [8] 0 0
At Days 15, 29, 57, 85 and 141
Secondary outcome [9] 0 0
Percentage of patients with at least a 50% reduction from Baseline in EASI (EASI 50)
Timepoint [9] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [10] 0 0
Percentage of patients with at least a 75% reduction from Baseline in EASI (EASI 75)
Timepoint [10] 0 0
At Days 15, 29, 57, 85, and 141
Secondary outcome [11] 0 0
Percentage of patients with at least a 90% reduction from Baseline in EASI (EASI 90)
Timepoint [11] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [12] 0 0
Percentage of patients with a 100% reduction from Baseline in EASI (EASI 100)
Timepoint [12] 0 0
At Days 15, 29, 57, 85, 113, 141 and 169
Secondary outcome [13] 0 0
Change in IGA (Investigator Global Assessment) from Baseline
Timepoint [13] 0 0
Baseline to day 113 and over time up to Day 365
Secondary outcome [14] 0 0
Percentage of patients with a score of IGA (Investigator Global Assessment) 0 or 1 and a reduction from Baseline of = 2 points
Timepoint [14] 0 0
At Days 15, 29, 57, 85, and 141
Secondary outcome [15] 0 0
Absolute and Percentage change in SCORAD (SCORing Atopic Dermatitis) Index from Baseline
Timepoint [15] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [16] 0 0
Absolute and Percentage change in affected BSA from Baseline
Timepoint [16] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [17] 0 0
Absolute and Percentage change in Patient Oriented Eczema Measure (POEM) from Baseline
Timepoint [17] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [18] 0 0
Absolute and Percentage change in Dermatology Life Quality Index (DLQI) from Baseline
Timepoint [18] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [19] 0 0
Absolute and Percentage change in Atopic Dermatitis Control Tool (ADCT) from Baseline
Timepoint [19] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [20] 0 0
Absolute and Percentage change in Hospital Anxiety and Depression Scale (HADS) from Baseline
Timepoint [20] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [21] 0 0
Absolute and Percentage change in weekly average of pruritus Numerical Rating Scale (NRS) from Baseline
Timepoint [21] 0 0
Baseline to Day 169 and over time up to Day 365
Secondary outcome [22] 0 0
Proportion of patients with improvement (reduction) of weekly average of pruritus NRS (Numerical Rating Scale) = 3 with a baseline pruritus NRS = 3 from baseline
Timepoint [22] 0 0
Baseline to Days 113 and 169
Secondary outcome [23] 0 0
Incidence of positive anti-Ky1005 antibody response
Timepoint [23] 0 0
Baseline through Day 477
Secondary outcome [24] 0 0
Time to loss of EASI 75
Timepoint [24] 0 0
Week 24 to Day 365
Secondary outcome [25] 0 0
Time to loss of IGA 0/1 (Patients with a response of 0 or 1 in IGA)
Timepoint [25] 0 0
Week 24 to Day 365
Secondary outcome [26] 0 0
Time to loss of EASI 50
Timepoint [26] 0 0
Week 24 to Day 365
Secondary outcome [27] 0 0
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR)
Timepoint [27] 0 0
Pre-op, 6 weeks, 6 months, 2 years and 5 years
Secondary outcome [28] 0 0
Patient Reported Outcomes - Oxford Knee Score (OKS)
Timepoint [28] 0 0
Pre-op, 6 weeks, 6 months, 2 years and 5 years
Secondary outcome [29] 0 0
Patient Reported Outcomes - Forgotten Joint Score (FJS)
Timepoint [29] 0 0
Pre-op, 6 weeks, 6 months, 2 years and 5 years
Secondary outcome [30] 0 0
Radiographic Assessment - Implant Position
Timepoint [30] 0 0
6 months, 2 years and 5 years
Secondary outcome [31] 0 0
Radiographic Assessment - Implant Migration
Timepoint [31] 0 0
6 months, 2 years and 5 years
Secondary outcome [32] 0 0
Radiographic Assessment - Progressive Radiolucency
Timepoint [32] 0 0
6 months, 2 years and 5 years
Secondary outcome [33] 0 0
Radiographic Assessment - Implant Loosening
Timepoint [33] 0 0
6 months, 2 years and 5 years
Secondary outcome [34] 0 0
Post-Operation Device Related Re-Interventions Related to Operative Knee
Timepoint [34] 0 0
Post-op through study completion, approximately 5 years
Secondary outcome [35] 0 0
Implant Survival Rate Up to 5 Years Post-Operation
Timepoint [35] 0 0
1 year, 2 years and 5 years
Secondary outcome [36] 0 0
Objective Response Rate (ORR)
Timepoint [36] 0 0
From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
Secondary outcome [37] 0 0
Duration of response (DoR)
Timepoint [37] 0 0
From the first documented response to confirmed progressive disease or death ( approx. 2 years )
Secondary outcome [38] 0 0
Progression free Survival (PFS)
Timepoint [38] 0 0
From first dose of AZD8205 to progressive disease or death in the absence of disease progression ( approx. 2 years )
Secondary outcome [39] 0 0
Disease Control Rate at 12 weeks (DCR-12)
Timepoint [39] 0 0
Measured from first dose until progression. For each patient, this is expected to be at 12 weeks
Secondary outcome [40] 0 0
Overall Survival (OS)
Timepoint [40] 0 0
From first dose of AZD8205 to death ( approx. 2 years )
Secondary outcome [41] 0 0
Pharmacokinetics of AZD8205: Area Under the concentration-time curve (AUC)
Timepoint [41] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [42] 0 0
Pharmacokinetics of AZD8205: Maximum plasma concentration of the study drug (Cmax)
Timepoint [42] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [43] 0 0
Pharmacokinetics of AZD8205: Time to maximum plasma concentration of the study drug (T-max)
Timepoint [43] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [44] 0 0
Pharmacokinetics of AZD8205: Clearance
Timepoint [44] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [45] 0 0
Pharmacokinetics of AZD8205: Terminal elimination half-life (t 1/2)
Timepoint [45] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [46] 0 0
Immunogenicity of AZD8205.
Timepoint [46] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [47] 0 0
Sub Study 1: AZD8205 monotherapy Pharmacodynamics
Timepoint [47] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [48] 0 0
Sub Study 2: AZD8205 in combination with AZD2936 Pharmacodynamics
Timepoint [48] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD8205 ( approx 2 years )
Secondary outcome [49] 0 0
Spike antibody durability
Timepoint [49] 0 0
6 months post-second vaccine dose
Secondary outcome [50] 0 0
Spike antibody seropositive persistence
Timepoint [50] 0 0
6 months post-second vaccine dose

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.
* EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline.
* IGA of 3 or 4 at Baseline.
* AD involvement of 10% or more of body surface area (BSA) at Baseline.
* Baseline worst/maximum pruritus 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/02/2024
Sample size
Target
Accrual to date
Final
390
Recruitment in Australia
Recruitment state(s)
QLD,VIC,NSW,SA
Recruitment hospital [1] 0 0
Neurocrine Clinical Site - Brisbane
Recruitment hospital [2] 0 0
Investigative Site Number 3002 - Carlton
Recruitment hospital [3] 0 0
Investigative Site Number: 3003 - East Melbourne
Recruitment hospital [4] 0 0
Investigational Site Number: 3001 - Parkville
Recruitment hospital [5] 0 0
Neurocrine Clinical Site - Melbourne
Recruitment hospital [6] 0 0
St George and Sutherland Centre for Clinical Orthopaedic Research - Sydney
Recruitment hospital [7] 0 0
OrthoSport Victoria - Melbourne
Recruitment hospital [8] 0 0
Robina Hospital - Robina
Recruitment hospital [9] 0 0
The Avenue Hospital - Windsor
Recruitment hospital [10] 0 0
PersonalEYES - Parramatta
Recruitment hospital [11] 0 0
Eye Associates - Sydney
Recruitment hospital [12] 0 0
Armadale Eye Clinic - Armadale
Recruitment hospital [13] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [14] 0 0
North West Eye Specialists - Gladstone Park
Recruitment hospital [15] 0 0
Centre for Eye Research Australia (CERA) - Melbourne
Recruitment hospital [16] 0 0
Waverely Eye Clinic - Waverley
Recruitment hospital [17] 0 0
Research Site - Clayton
Recruitment hospital [18] 0 0
Research Site - Melbourne
Recruitment hospital [19] 0 0
Research Site - Nedlands
Recruitment hospital [20] 0 0
Research Site - South Brisbane
Recruitment hospital [21] 0 0
ARASMI - Adelaide
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Melbourne
Recruitment postcode(s) [7] 0 0
3065 - Melbourne
Recruitment postcode(s) [8] 0 0
3084 - Melbourne
Recruitment postcode(s) [9] 0 0
- Sydney
Recruitment postcode(s) [10] 0 0
3121 - Melbourne
Recruitment postcode(s) [11] 0 0
3121 - Robina
Recruitment postcode(s) [12] 0 0
3181 - Windsor
Recruitment postcode(s) [13] 0 0
2150 - Parramatta
Recruitment postcode(s) [14] 0 0
2000 - Sydney
Recruitment postcode(s) [15] 0 0
3143 - Armadale
Recruitment postcode(s) [16] 0 0
3065 - Fitzroy
Recruitment postcode(s) [17] 0 0
3403 - Gladstone Park
Recruitment postcode(s) [18] 0 0
3002 - Melbourne
Recruitment postcode(s) [19] 0 0
3150 - Waverley
Recruitment postcode(s) [20] 0 0
3168 - Clayton
Recruitment postcode(s) [21] 0 0
VIC 3000 - Melbourne
Recruitment postcode(s) [22] 0 0
6009 - Nedlands
Recruitment postcode(s) [23] 0 0
4101 - South Brisbane
Recruitment postcode(s) [24] 0 0
5042 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Pleven
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Stara Zagora
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Czechia
State/province [18] 0 0
Jihomoravský Kraj
Country [19] 0 0
Czechia
State/province [19] 0 0
Moravskoslezský Kraj
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha, Hlavní Mesto
Country [21] 0 0
Czechia
State/province [21] 0 0
Kutná Hora
Country [22] 0 0
Czechia
State/province [22] 0 0
Ostrava
Country [23] 0 0
Germany
State/province [23] 0 0
Bayern
Country [24] 0 0
Germany
State/province [24] 0 0
Brandenburg
Country [25] 0 0
Germany
State/province [25] 0 0
Nordrhein-Westfalen
Country [26] 0 0
Germany
State/province [26] 0 0
Schleswig-Holstein
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Hungary
State/province [29] 0 0
Bács-Kiskun
Country [30] 0 0
Hungary
State/province [30] 0 0
Békés
Country [31] 0 0
Hungary
State/province [31] 0 0
Csongrád
Country [32] 0 0
Hungary
State/province [32] 0 0
Hajdú-Bihar
Country [33] 0 0
Hungary
State/province [33] 0 0
Jász-Nagykun-Szolnok
Country [34] 0 0
Hungary
State/province [34] 0 0
Zala
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Japan
State/province [36] 0 0
Hokkaidô
Country [37] 0 0
Japan
State/province [37] 0 0
Kagosima
Country [38] 0 0
Japan
State/province [38] 0 0
Kanagawa
Country [39] 0 0
Japan
State/province [39] 0 0
Tiba
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
Japan
State/province [41] 0 0
Kyoto-Shi
Country [42] 0 0
Japan
State/province [42] 0 0
Mibu-machi
Country [43] 0 0
Japan
State/province [43] 0 0
Sapporo
Country [44] 0 0
Japan
State/province [44] 0 0
Ôsaka
Country [45] 0 0
Poland
State/province [45] 0 0
Dolnoslaskie
Country [46] 0 0
Poland
State/province [46] 0 0
Lodzkie
Country [47] 0 0
Poland
State/province [47] 0 0
Lódzkie
Country [48] 0 0
Poland
State/province [48] 0 0
Malopolskie
Country [49] 0 0
Poland
State/province [49] 0 0
Mazowieckie
Country [50] 0 0
Poland
State/province [50] 0 0
Podkarpackie
Country [51] 0 0
Poland
State/province [51] 0 0
Podlaskie
Country [52] 0 0
Poland
State/province [52] 0 0
Pomorskie
Country [53] 0 0
Poland
State/province [53] 0 0
Slaskie
Country [54] 0 0
Poland
State/province [54] 0 0
Zachodniopomorskie
Country [55] 0 0
Poland
State/province [55] 0 0
Bialystok
Country [56] 0 0
Poland
State/province [56] 0 0
Gdansk
Country [57] 0 0
Poland
State/province [57] 0 0
Krakow
Country [58] 0 0
Poland
State/province [58] 0 0
Lódz
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Spain
State/province [60] 0 0
Alicante
Country [61] 0 0
Spain
State/province [61] 0 0
Córdoba
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Pontevedra
Country [64] 0 0
Taiwan
State/province [64] 0 0
Niao Song Qu
Country [65] 0 0
Taiwan
State/province [65] 0 0
Taichung
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Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kymab Limited
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian Respiratory and Sleep Medicine Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Cinnagen
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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 LTE (Long-Term Extension) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.
Trial website
https://clinicaltrials.gov/study/NCT05131477
Trial related presentations / publications
Kinneer K, Wortmann P, Cooper ZA, Dickinson NJ, Masterson L, Cailleau T, Hutchinson I, Vijayakrishnan B, McFarlane M, Ball K, Davies M, Lewis A, Huang Y, Rosenbaum AI, Yuan J, Chesebrough J, Anderton J, Monks N, Novick S, Wang J, Dimasi N, Christie RJ, Sabol D, Tosto FA, Wallez Y, Leo E, Albertella MR, Staniszewska AD, Tice DA, Howard PW, Luheshi N, Sapra P. Design and Preclinical Evaluation of a Novel B7-H4-Directed Antibody-Drug Conjugate, AZD8205, Alone and in Combination with the PARP1-Selective Inhibitor AZD5305. Clin Cancer Res. 2023 Mar 14;29(6):1086-1101. doi: 10.1158/1078-0432.CCR-22-2630.
Li L, Honda-Okubo Y, Huang Y, Jang H, Carlock MA, Baldwin J, Piplani S, Bebin-Blackwell AG, Forgacs D, Sakamoto K, Stella A, Turville S, Chataway T, Colella A, Triccas J, Ross TM, Petrovsky N. Immunisation of ferrets and mice with recombinant SARS-CoV-2 spike protein formulated with Advax-SM adjuvant protects against COVID-19 infection. Vaccine. 2021 Sep 24;39(40):5940-5953. doi: 10.1016/j.vaccine.2021.07.087. Epub 2021 Aug 3.
Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Roshanzamir K, Bayatani B, Taheri A, Petrovsky N, Li L, Barati S. Safety and immunogenicity of SpikoGen(R), an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations. Clin Microbiol Infect. 2022 Sep;28(9):1263-1271. doi: 10.1016/j.cmi.2022.04.004. Epub 2022 Apr 15.
Li L, Honda-Okubo Y, Baldwin J, Bowen R, Bielefeldt-Ohmann H, Petrovsky N. Covax-19/Spikogen(R) vaccine based on recombinant spike protein extracellular domain with Advax-CpG55.2 adjuvant provides single dose protection against SARS-CoV-2 infection in hamsters. Vaccine. 2022 May 20;40(23):3182-3192. doi: 10.1016/j.vaccine.2022.04.041. Epub 2022 Apr 18.
Public notes

Contacts
Principal investigator
Name 0 0
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Country 0 0
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Contact person for public queries
Name 0 0
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05131477