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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03706040




Registration number
NCT03706040
Ethics application status
Date submitted
11/10/2018
Date registered
15/10/2018
Date last updated
18/11/2021

Titles & IDs
Public title
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Scientific title
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
Secondary ID [1] 0 0
2021-002203-34
Secondary ID [2] 0 0
M16-813
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Placebo
Treatment: Other - Risankizumab

Placebo comparator: Placebo - Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B.

Experimental: Risankizumab 150 mg - Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.

Experimental: Risankizumab 300 mg - Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.


Treatment: Other: Placebo
subcutaneous (SC) injection

Treatment: Other: Risankizumab
subcutaneous (SC) injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of = 2 Points at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved a Reduction of = 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16
Timepoint [2] 0 0
Baseline and Week 16
Secondary outcome [3] 0 0
Percent Change From Baseline in EASI Score at Week 16
Timepoint [3] 0 0
Baseline and Week 16
Secondary outcome [4] 0 0
Percent Change From Baseline in EASI Score at Week 28 and Week 52
Timepoint [4] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [5] 0 0
Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52
Timepoint [5] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [6] 0 0
Percentage of Participants Who Achieved an EASI 50 Response at Week 16
Timepoint [6] 0 0
Baseline and Week 16
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52
Timepoint [7] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved an EASI 90 Response at Week 16
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52
Timepoint [9] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of = 2 Points at Week 28 and Week 52
Timepoint [10] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [11] 0 0
Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16
Timepoint [11] 0 0
Baseline and Week 16
Secondary outcome [12] 0 0
Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52
Timepoint [12] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [13] 0 0
Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16
Timepoint [13] 0 0
Baseline, Week 16
Secondary outcome [14] 0 0
Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52
Timepoint [14] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [15] 0 0
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16
Timepoint [15] 0 0
Baseline and Week 16
Secondary outcome [16] 0 0
Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52
Timepoint [16] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [17] 0 0
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16
Timepoint [17] 0 0
Baseline and Week 16
Secondary outcome [18] 0 0
Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52
Timepoint [18] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [19] 0 0
Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16
Timepoint [19] 0 0
Week 16
Secondary outcome [20] 0 0
Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52
Timepoint [20] 0 0
Weeks 28 and 52
Secondary outcome [21] 0 0
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16
Timepoint [21] 0 0
Week 16
Secondary outcome [22] 0 0
Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52
Timepoint [22] 0 0
Weeks 28 and 52
Secondary outcome [23] 0 0
Percentage of Participants Who Achieved a Reduction in DLQI of = 4 Points From Baseline at Week 16 Among Those With a DLQI = 4 at Baseline
Timepoint [23] 0 0
Baseline and Week 16
Secondary outcome [24] 0 0
Percentage of Participants Who Achieved a Reduction in DLQI of = 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI = 4 at Baseline
Timepoint [24] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [25] 0 0
Change From Baseline in DLQI Score at Week 16
Timepoint [25] 0 0
Baseline and Week 16
Secondary outcome [26] 0 0
Change From Baseline in DLQI Score at Week 28 and Week 52
Timepoint [26] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [27] 0 0
Change From Baseline in CDLQI Score at Week 16
Timepoint [27] 0 0
Baseline and Week 16
Secondary outcome [28] 0 0
Change From Baseline in CDLQI Score at Week 28 and Week 52
Timepoint [28] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [29] 0 0
Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16
Timepoint [29] 0 0
Baseline and Week 16
Secondary outcome [30] 0 0
Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Timepoint [30] 0 0
Baseline and Weeks 28 and 52
Secondary outcome [31] 0 0
Percentage of Participants Who Achieved a Reduction of = 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52
Timepoint [31] 0 0
Baseline and Weeks 28 and 52

Eligibility
Key inclusion criteria
* adults who are = 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
* a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
* moderate to severe AD at the Baseline Visit
* history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
* concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments

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 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
27/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2021
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology /ID# 204778 - Phillip
Recruitment hospital [2] 0 0
St George Hospital /ID# 204780 - Kogarah
Recruitment hospital [3] 0 0
Veracity Clinical Research /ID# 204786 - Woolloongabba
Recruitment hospital [4] 0 0
North Eastern Health Specialists /ID# 204785 - Hectorville
Recruitment hospital [5] 0 0
Skin Health Institute Inc /ID# 204779 - Carlton
Recruitment hospital [6] 0 0
Fremantle Dermatology /ID# 204784 - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5073 - Hectorville
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
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Louisiana
Country [10] 0 0
United States of America
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Maryland
Country [11] 0 0
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Michigan
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Nevada
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New Jersey
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Dakota
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Tennessee
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United States of America
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Texas
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Virginia
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United States of America
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Washington
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Canada
State/province [25] 0 0
Alberta
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Canada
State/province [26] 0 0
Ontario
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Canada
State/province [27] 0 0
Quebec
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Japan
State/province [28] 0 0
Aichi
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Japan
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Fukuoka
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Japan
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Kanagawa
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Japan
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Niigata
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Puerto Rico
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Caguas
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Puerto Rico
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Carolina
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Puerto Rico
State/province [38] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
Trial website
https://clinicaltrials.gov/study/NCT03706040
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03706040