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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03926169




Registration number
NCT03926169
Ethics application status
Date submitted
23/04/2019
Date registered
24/04/2019

Titles & IDs
Public title
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Scientific title
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Secondary ID [1] 0 0
2019-000122-21
Secondary ID [2] 0 0
M16-833
Universal Trial Number (UTN)
Trial acronym
DETERMINED 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 0 0
Condition category
Condition code

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

Experimental: Risankizumab 180 mg - In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Experimental: Risankizumab 360 mg - In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Placebo comparator: Placebo - In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Experimental: Risankizumab 180 mg / Risankizumab 360 mg - In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.

Experimental: Risankizumab 360 mg / Risankizumab 360 mg - In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.

Placebo comparator: Placebo / Risankizumab 360 mg - In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.


Treatment: Drugs: Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)

Treatment: Drugs: Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Timepoint [1] 0 0
Baseline (Week 0), Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving = 30% Reduction and = 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) = 3
Timepoint [1] 0 0
Baseline (Week 0) to Week 8
Secondary outcome [2] 0 0
Percentage of Participants Achieving = 30% Reduction and = 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) = 3
Timepoint [2] 0 0
Baseline (Week 0) to Week 16
Secondary outcome [3] 0 0
Percentage of Participants Who Experienced = 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline
Timepoint [3] 0 0
Baseline (Week 0) to Week 16
Secondary outcome [4] 0 0
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Timepoint [4] 0 0
Baseline (Week 0) to Week 16
Secondary outcome [5] 0 0
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
Timepoint [5] 0 0
Baseline (Week 0) to Week 16
Secondary outcome [6] 0 0
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
Timepoint [6] 0 0
Baseline (Week 0) to Week 16
Secondary outcome [7] 0 0
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
Timepoint [7] 0 0
Baseline (Week 0) to Week 16

Eligibility
Key inclusion criteria
* Participant with moderate to severe HS for at least 1 year prior to baseline visit.
* HS lesions present in at least two distinct anatomical areas.
* Draining fistula count of = 20 at Baseline visit.
* Total abscess and inflammatory nodule (AN) count of = 5 at Baseline visit.
* Participants are required to use a daily antiseptic wash on their HS lesions.
* Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
* Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
* Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
* Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
* Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
* Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.

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
3/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2021
Sample size
Target
Accrual to date
Final
243
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Woden Dermatology /ID# 212437 - Phillip
Recruitment hospital [2] 0 0
Westmead Hospital /ID# 212438 - Westmead
Recruitment hospital [3] 0 0
Veracity Clinical Research /ID# 212432 - Woolloongabba
Recruitment hospital [4] 0 0
Skin Health Institute Inc /ID# 212433 - Carlton
Recruitment hospital [5] 0 0
Sinclair Dermatology /ID# 215548 - East Melbourne
Recruitment hospital [6] 0 0
The Royal Melbourne Hospital /ID# 212436 - Parkville
Recruitment hospital [7] 0 0
Fremantle Dermatology /ID# 212434 - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
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
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
New Brunswick
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
France
State/province [21] 0 0
Alpes-Maritimes
Country [22] 0 0
France
State/province [22] 0 0
Ile-de-France
Country [23] 0 0
France
State/province [23] 0 0
Loire
Country [24] 0 0
France
State/province [24] 0 0
Lyon
Country [25] 0 0
France
State/province [25] 0 0
Reims
Country [26] 0 0
France
State/province [26] 0 0
Toulouse
Country [27] 0 0
Germany
State/province [27] 0 0
Hessen
Country [28] 0 0
Germany
State/province [28] 0 0
Bochum
Country [29] 0 0
Germany
State/province [29] 0 0
Dessau
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Japan
State/province [31] 0 0
Aichi
Country [32] 0 0
Japan
State/province [32] 0 0
Fukuoka
Country [33] 0 0
Japan
State/province [33] 0 0
Miyagi
Country [34] 0 0
Japan
State/province [34] 0 0
Okinawa
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Netherlands
State/province [36] 0 0
Noord-Brabant
Country [37] 0 0
Netherlands
State/province [37] 0 0
Zuid-Holland
Country [38] 0 0
Netherlands
State/province [38] 0 0
Breda
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
Spain
State/province [41] 0 0
Alicante
Country [42] 0 0
Spain
State/province [42] 0 0
Granada
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Malaga

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://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


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/NCT03926169