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A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (DETERMINED 1)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926169
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date June 23, 2020
Actual Study Start Date  ICMJE June 3, 2019
Estimated Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: Week 16 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Percentage of participants achieving at least 30% reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) at Week 8 among participants with Baseline Numerical Rating Scale (NRS) >= 3 [ Time Frame: Baseline (Week 0) to approximately Week 8 ]
    NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain).
  • Percentage of participants achieving at least 30% reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) at Week 16 among participants with Baseline Numerical Rating Scale (NRS) >= 3 [ Time Frame: Baseline (Week 0) to approximately Week 16 ]
    NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain).
  • Percentage of participants who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline [ Time Frame: Baseline (Week 0) to approximately Week 16 ]
    Percentage of participants who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline is evaluated
  • Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline (Week 0) to approximately Week 16 ]
    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.
  • Change from Baseline in HS-related swelling assessed based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) [ Time Frame: Baseline (Week 0) to approximately Week 16 ]
    HSSA is a 9-item patient reported outcome (PRO) questionnaire developed to assess the symptoms of HS on a 0 to 11-point numerical rating scale (NRS), where 0 represents no symptoms and 10 represents extreme symptom experience.
  • Change from Baseline in HS-related odor assessed based on the HSSA [ Time Frame: Baseline (Week 0) to approximately Week 16 ]
    HSSA is a 9-item patient reported outcome (PRO) questionnaire developed to assess the symptoms of HS on a 0 to 11-point numerical rating scale (NRS), where 0 represents no symptoms and 10 represents extreme symptom experience.
  • Change from Baseline in HS-related worst drainage assessed based on the HSSA [ Time Frame: Baseline (Week 0) to approximately Week 16 ]
    HSSA is a 9-item patient reported outcome (PRO) questionnaire developed to assess the symptoms of HS on a 0 to 11-point numerical rating scale (NRS), where 0 represents no symptoms and 10 represents extreme symptom experience.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Official Title  ICMJE 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
Brief Summary This study is to evaluate the safety and efficacy of 2 dose levels of risankizumab in adult participants with moderate to severe Hidradenitis Suppurativa (HS). This study includes two treatment periods. In Period A, participants are randomized to receive either risankizumab dose A, dose B, or placebo. In Period B, participants who received risankizumab dose A or placebo during Period A, will receive risankizumab dose B. Participants who received risankizumab dose B in Period A will remain on that dose in Period B.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE
  • Drug: Risankizumab
    Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
    Other Names:
    • ABBV-066
    • SKYRIZI
  • Drug: Placebo for risankizumab
    Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Study Arms  ICMJE
  • Experimental: Risankizumab: Dose A
    Participants randomized to receive risankizumab dose A in treatment period A and placebo followed by risankizumab dose B in treatment period B
    Interventions:
    • Drug: Risankizumab
    • Drug: Placebo for risankizumab
  • Experimental: Risankizumab: Dose B
    Participants randomized to receive risankizumab dose B in treatment period A and placebo followed by risankizumab dose B in treatment period B
    Interventions:
    • Drug: Risankizumab
    • Drug: Placebo for risankizumab
  • Placebo Comparator: Placebo
    Participants randomized to receive Placebo in treatment period A and risankizumab dose B in treatment period B
    Interventions:
    • Drug: Risankizumab
    • Drug: Placebo for risankizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2020)
220
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
190
Estimated Study Completion Date  ICMJE June 13, 2022
Estimated Primary Completion Date November 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant with moderate to severe Hidradenitis Suppurativa (HS) for at least one year prior to baseline visit.
  • HS lesions present in at least two distinct anatomical areas.
  • Draining fistula count of <=20 at Baseline visit.
  • Total abscesses and nodule count (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.

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 immuno deficiency 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Canada,   France,   Germany,   Japan,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926169
Other Study ID Numbers  ICMJE M16-833
2019-000122-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: 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 Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP