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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. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Risankizumab Drug: Placebo for risankizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : February 2, 2021
Actual Study Completion Date : August 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Other Names:
  • ABBV-066
  • SKYRIZI
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.
 Drug: Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Other Names:
  • ABBV-066
  • SKYRIZI
Placebo Comparator: Placebo
In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
 Drug: Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS
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.

 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
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.

 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
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.

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]
  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926169


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] December 15, 2020
Statistical Analysis Plan  [PDF] January 19, 2021

More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03926169    
Other Study ID Numbers: M16-833
2019-000122-21 ( EudraCT Number )
First Posted: April 24, 2019    Key Record Dates
Results First Posted: August 11, 2022
Last Update Posted: August 11, 2022
Last Verified: July 2022
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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

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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
Keywords provided by AbbVie:
Hidradenitis Suppurativa
Risankizumab
Placebo
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
 Infections
Skin Diseases, Infectious
Suppuration
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs