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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

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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
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
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
South Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Japan
State/province [28] 0 0
Aichi
Country [29] 0 0
Japan
State/province [29] 0 0
Fukuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Kanagawa
Country [31] 0 0
Japan
State/province [31] 0 0
Niigata
Country [32] 0 0
Japan
State/province [32] 0 0
Okinawa
Country [33] 0 0
Japan
State/province [33] 0 0
Osaka
Country [34] 0 0
Japan
State/province [34] 0 0
Shizuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Puerto Rico
State/province [36] 0 0
Caguas
Country [37] 0 0
Puerto Rico
State/province [37] 0 0
Carolina
Country [38] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03706040