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

• ClinicalTrials.gov Identifier: NCT03926169
• Recruitment Status: Completed
• First Posted: April 24, 2019
• Results First Posted: August 11, 2022
• Last Update Posted: August 11, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: April 23, 2019
• First Posted Date: April 24, 2019
• Results First Submitted Date: July 14, 2022
• Results First Posted Date: August 11, 2022
• Last Update Posted Date: August 11, 2022
• Actual Study Start Date: June 3, 2019
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2022)

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 [ Time Frame: Baseline (Week 0), 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 (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.

Current Secondary Outcome Measures (submitted: July 14, 2022)

• 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 [ Time Frame: Baseline (Week 0) to Week 8 ]
  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.
• 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 [ Time Frame: Baseline (Week 0) to Week 16 ]
  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.
• 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 [ Time Frame: Baseline (Week 0) to Week 16 ]
• Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 [ Time Frame: Baseline (Week 0) to 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. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.
• Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16 [ Time Frame: Baseline (Week 0) to Week 16 ]
  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.
• Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16 [ Time Frame: Baseline (Week 0) to Week 16 ]
  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.
• Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16 [ Time Frame: Baseline (Week 0) to Week 16 ]
  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.

Original Secondary Outcome Measures (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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
• Official 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hidradenitis Suppurativa

Intervention

• Drug: Risankizumab
  Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
  Other Names:

  • ABBV-066
  • SKYRIZI
• Drug: Placebo for risankizumab
  Placebo for risankizumab is administered as a SC injection in PFS

Study Arms

• 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.
  Intervention: Drug: Risankizumab
• 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.
  Intervention: Drug: Risankizumab
• Placebo Comparator: Placebo
  In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
  Intervention: Drug: Placebo for risankizumab
• 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.

  Interventions:

  • Drug: Risankizumab
  • Drug: Placebo for risankizumab
• 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.

  Interventions:

  • Drug: Risankizumab
  • Drug: Placebo for risankizumab
• 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.

  Interventions:

  • Drug: Risankizumab
  • Drug: Placebo for risankizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 4, 2021): 243
• Original Estimated Enrollment (submitted: April 23, 2019): 190
• Actual Study Completion Date: August 2, 2021
• Actual Primary Completion Date: February 2, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, France, Germany, Japan, Netherlands, Spain, United States

Administrative Information

• NCT Number: NCT03926169
• Other Study ID Numbers: 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

• 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: For details on when studies are available for sharing, please refer to the link below.
• 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 Use Agreement (DUA). 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

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: July 2022