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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 : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

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)
Estimated Enrollment : 220 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
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : April 26, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 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)
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
 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)
Placebo Comparator: Placebo
Participants randomized to receive Placebo in treatment period A and risankizumab dose B in treatment period B
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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 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.
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
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
Last Update Posted: January 8, 2021
Last Verified: January 2021
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: 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

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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
 Skin Diseases, Infectious
Infection
Suppuration
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs