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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03926169
Registration number
NCT03926169
Ethics application status
Date submitted
23/04/2019
Date registered
24/04/2019
Date last updated
11/08/2022
Titles & IDs
Public title
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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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
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Secondary ID [1]
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2019-000122-21
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Secondary ID [2]
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M16-833
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Universal Trial Number (UTN)
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Trial acronym
DETERMINED 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
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Assessment method [1]
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HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.
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Timepoint [1]
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Baseline (Week 0), Week 16
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Secondary outcome [1]
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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
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Assessment method [1]
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NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS = 3, is presented.
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Timepoint [1]
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Baseline (Week 0) to Week 8
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Secondary outcome [2]
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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
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Assessment method [2]
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NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS = 3, is presented.
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Timepoint [2]
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Baseline (Week 0) to Week 16
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Secondary outcome [3]
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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
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Assessment method [3]
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Timepoint [3]
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Baseline (Week 0) to Week 16
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Secondary outcome [4]
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Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
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Assessment method [4]
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The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.
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Timepoint [4]
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Baseline (Week 0) to Week 16
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Secondary outcome [5]
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Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
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Assessment method [5]
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HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
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Timepoint [5]
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Baseline (Week 0) to Week 16
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Secondary outcome [6]
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Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
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Assessment method [6]
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HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
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Timepoint [6]
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Baseline (Week 0) to Week 16
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Secondary outcome [7]
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Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
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Assessment method [7]
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HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.
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Timepoint [7]
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Baseline (Week 0) to Week 16
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/06/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/08/2021
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Sample size
Target
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Accrual to date
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Final
243
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Woden Dermatology /ID# 212437 - Phillip
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Recruitment hospital [2]
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Westmead Hospital /ID# 212438 - Westmead
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Recruitment hospital [3]
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Veracity Clinical Research /ID# 212432 - Woolloongabba
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Recruitment hospital [4]
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Skin Health Institute Inc /ID# 212433 - Carlton
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Recruitment hospital [5]
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Sinclair Dermatology /ID# 215548 - East Melbourne
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Recruitment hospital [6]
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The Royal Melbourne Hospital /ID# 212436 - Parkville
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Recruitment hospital [7]
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Fremantle Dermatology /ID# 212434 - Fremantle
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3053 - Carlton
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Recruitment postcode(s) [5]
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3002 - East Melbourne
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment postcode(s) [7]
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6160 - Fremantle
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Recruitment outside Australia
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United States of America
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Arkansas
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California
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Connecticut
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Illinois
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Granada
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Madrid
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Malaga
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to assess the safety and efficacy of risankizumab 180
mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe
hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before
the Baseline visit.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03926169
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03926169
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