A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

• ClinicalTrials.gov Identifier: NCT03926169
• Recruitment Status: Recruiting
• First Posted: April 24, 2019
• Last Update Posted: October 14, 2019
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 190 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: October 2, 2020
• Estimated Study Completion Date: January 24, 2022

Arms and Interventions

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 Name: ABBV-066; 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 Name: ABBV-066; 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 Name: ABBV-066; Drug: Placebo for risankizumab; Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)

Outcome Measures

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

• 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

Contacts

Contact: ABBVIE CALL CENTER; 847.283.8955; abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators

AbbVie

Investigators

• Study Director: AbbVie Inc.; AbbVie

More Information

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03926169 History of Changes
• Other Study ID Numbers: M16-833; 2019-000122-21 ( EudraCT Number )
• First Posted: April 24, 2019
• Last Update Posted: October 14, 2019
• Last Verified: October 2019

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); Analytic Code
• 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

• 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:

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