A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
NCT Number: NCT06468228
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hidradenitis Suppurativa
Interventions: DRUG: Lutikizumab|DRUG: Placebo
Sponsor: AbbVie
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1280
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2026-12-14
Locations: Cahaba Dermatology & Skin Health Center /ID# 263795, Birmingham, Alabama, 35244, United States|Medical Dermatology Specialists /ID# 263394, Phoenix, Arizona, 85006, United States|Dermatology Trial Associates /ID# 264587, Bryant, Arkansas, 72022, United States|Arkansas Research Trials /ID# 263901, North Little Rock, Arkansas, 72217, United States|Joseph Raoof Md,Inc /Id# 263756, Encino, California, 91436, United States|Dermatology Research Associates - Los Angeles /ID# 263765, Los Angeles, California, 90045, United States|Integrative Skin Science and Research /ID# 264600, Sacramento, California, 95815, United States|Clinical Trials Research Institute /ID# 263743, Thousand Oaks, California, 91320, United States|TrueBlue Clinical Research /ID# 265041, Brandon, Florida, 33511, United States|GSI Clinical Research, LLC /ID# 263827, Margate, Florida, 33063-7011, United States|Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842, Ocala, Florida, 34470, United States|Skin Care Research - Tampa /ID# 263819, Tampa, Florida, 33607-6438, United States|Centricity Research Columbus Dermatology /ID# 266530, Columbus, Georgia, 31904, United States|Cleaver Medical Group Dermatology /ID# 263845, Dawsonville, Georgia, 30534, United States|Treasure Valley Medical Research /ID# 263671, Boise, Idaho, 83706, United States|Arlington Dermatology /ID# 263410, Rolling Meadows, Illinois, 60008, United States|Dawes Fretzin, LLC /ID# 264601, Indianapolis, Indiana, 46256, United States|Dermatology Partners of Leawood /ID# 263533, Leawood, Kansas, 66211, United States|Michigan Center for Medical Research /ID# 263547, Clarkston, Michigan, 48346, United States|Dermatology and Skin Center of Lees Summit /ID# 263567, Lee's Summit, Missouri, 64064-2301, United States|ActivMed Practices & Research - Portsmouth /ID# 263387, Portsmouth, New Hampshire, 03801, United States|Dermatology of Greater Columbus /ID# 263497, Bexley, Ohio, 43209, United States|Dermatologists of Southwest Ohio - Mason /ID# 263588, Mason, Ohio, 45040, United States|Clinical Research Center of the Carolinas /ID# 263407, Charleston, South Carolina, 29407, United States|Arlington Research Center, Inc /ID# 263895, Arlington, Texas, 76011, United States|Bellaire Dermatology Associates /ID# 263850, Bellaire, Texas, 77401, United States|Studies in Dermatology LLC /ID# 263399, Cypress, Texas, 77429, United States|Reveal Research Institute, Dallas /ID# 267233, Dallas, Texas, 75235-2519, United States|Center for Clinical Studies - Houston - Binz Street /ID# 263378, Houston, Texas, 77004, United States|Texas Dermatology and Laser Specialists /ID# 263778, San Antonio, Texas, 78218, United States|Dermatology Associates of Tyler /ID# 265002, Tyler, Texas, 75703, United States|Virginia Clinical Research, Inc. /ID# 264553, Norfolk, Virginia, 23502, United States|Dermatology Specialists of Spokane /ID# 264499, Spokane, Washington, 99202, United States|Clinical Research Puerto Rico /ID# 263450, San Juan, 00909-1711, Puerto Rico

Summary:
Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with moderate to severe HS .

Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms.

In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

Primary Outcome Measures: Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75, HiSCR 75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula count relative to baseline., At Week 16|Number of Participants with Adverse Events (AEs), An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment., Up to Approximately Week 62
Secondary Outcome Measures: Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3, NRS 30 is defined as at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain), as assessed by the Patient's Global Assessment (PGA) of Skin Pain., At Week 8|Change from Baseline in Dermatology Life Quality Index (DLQI), DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no effect) to 30 (very large effect), with a higher score indicating a more impaired quality of life., At Week 16|Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA), The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact., At Week 16|Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score, The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (HS) in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience., At Week 16|Change from Baseline in Draining Fistula Count, At Week 16|Percentage of Participants Achieving HiSCR 90, HiSCR 90 is defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula count relative to baseline., At Week 16|Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS), At Week 8|Change from Baseline in HSSA, The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (HS) in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience., At Week 16|Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8, The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience., At Week 16|Percentage of Participants with an Occurrence of HS Flare in Period 1, HS Flare is defined as at least one occurrence of a ≥ 25% increase in AN count with a minimum absolute increase of 2 relative to Baseline., Baseline to Week 16