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
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03706040
Ethics application status
Date submitted
11/10/2018
Date registered
11/10/2018
Date last updated
8/02/2019

Titles & IDs
Public title
A Study to Evaluate Risankizumab in Adult and Adolescent Subjects 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
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
Other interventions - placebo for rizankizumab
Other interventions - risankizumab

Placebo Comparator: Placebo - Participants randomized to receive double-blind (DB) placebo for 16 weeks (Period A) followed by either DB risankizumab Dose 1 or DB risankizumab Dose 2 for 24 weeks (Period B).

Experimental: Risankizumab Dose 1 - Participants randomized to receive double-blind (DB) risankizumab Dose 1 for 16 weeks (Period A) followed by DB risankizumab Dose 1 for 24 weeks (Period B).

Experimental: Risankizumab Dose 2 - Participants randomized to receive double-blind (DB) risankizumab Dose 2 for 16 weeks (Period A) followed by DB risankizumab Dose 2 for 24 weeks (Period B).


Other interventions: placebo for rizankizumab
subcutaneous (SC) injection

Other interventions: risankizumab
subcutaneous (SC) injection

Intervention code [1] 0 0
Other interventions
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) - The EASI is a tool used to measure the area and severity of atopic eczema.
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of "0" Or "1" With a Reduction From Baseline of = 2 Points - The vIGA-AD is a validated assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally.
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants Achieving a Reduction of = 4 Points in Worst Pruritus Numerical Rating Scale (NRS) from Baseline - The Worst Pruritis NRS asks the participant to rate itch (pruritis) intensity at its worst during the past 24 hours.
Timepoint [2] 0 0
Baseline, Week 16

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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 Specialis /ID# 204785 - Hectorville
Recruitment hospital [5] 0 0
Skin and Cancer Foundation /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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Rhode Island
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Okinawa
Country [24] 0 0
Japan
State/province [24] 0 0
Osaka
Country [25] 0 0
Japan
State/province [25] 0 0
Shizuoka
Country [26] 0 0
Japan
State/province [26] 0 0
Tokyo

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 adult and adolescent subjects.
Trial website
https://clinicaltrials.gov/show/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
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable