A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
- Registration Number
- NCT06468228
- Lead Sponsor
- AbbVie
- Brief 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 the signs and symptoms of 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.
Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks.
Participants in the US that complete Periods 1 \& 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1280
- Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
- Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
- Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
- Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Confirmed positive anti-HIV antibody (HIV Ab) test.
- Evidence of active tuberculosis or meets tuberculosis exclusionary parameter
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Period 2: Placebo to Lutikizumab Group Every Other Week Lutikizumab The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52 Period 2: Placebo to Lutikizumab Group Every Other Week Placebo The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52 Period 3: Open-label Lutikizumab Lutikizumab Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week Sub-Study: Lutikizumab Pre-Filled Pen Lutikizumab Lutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks. Period 1 Lutikizumab Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 . Period 1 Placebo Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 . Period 2: Lutikizumab Every Week Lutikizumab Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52 Period 2: Lutikizumab Every Other Week Lutikizumab Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52 Period 2: Lutikizumab Every Other Week Placebo Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52 Period 2: Placebo to Lutikizumab Group Lutikizumab Participants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week. Period 2: Placebo to Lutikizumab Group Every Week Lutikizumab Participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Up to Approximately Week 62 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.
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75 At Week 16 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline At Week 16 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.
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) At Week 16 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.
Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score At Week 16 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.
Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline At Week 16 Percentage of Participants Achieving HiSCR 90 At Week 16 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.
Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) At Week 8 Change from Baseline in HSSA At Week 16 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.
Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8 At Week 16 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.
Percentage of Participants with an Occurrence of HS Flare in Period 1 Baseline to Week 16 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.
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain At Week 16 Change from Baseline in HSIA Mobility Domain at Week 16 Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 At Week 8 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.
Trial Locations
- Locations (240)
Reveal Research Institute - Dallas /ID# 267233
🇺🇸Dallas, Texas, United States
Grupo Clinico CATEI S C /ID# 265276
🇲🇽Guadalajara, Jalisco, Mexico
Cahaba Dermatology & Skin Health Center /ID# 263795
🇺🇸Birmingham, Alabama, United States
Medical Dermatology Specialists /ID# 263394
🇺🇸Phoenix, Arizona, United States
Dermatology Trial Associates /ID# 264587
🇺🇸Bryant, Arkansas, United States
Arkansas Research Trials /ID# 263901
🇺🇸North Little Rock, Arkansas, United States
Private Practice - Dr. Tooraj Raoof /ID# 263756
🇺🇸Encino, California, United States
Dermatology Research Associates - Los Angeles /ID# 263765
🇺🇸Los Angeles, California, United States
Stanford University School of Medicine - Redwood City /ID# 263711
🇺🇸Redwood City, California, United States
Integrative Skin Science and Research /ID# 264600
🇺🇸Sacramento, California, United States
Scroll for more (230 remaining)Reveal Research Institute - Dallas /ID# 267233🇺🇸Dallas, Texas, United States