A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
- 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.
- Acronym
- Intrepid
- Short title
- A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
- Official title
- A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-12-01
- First posted
- 2024-06-21
- Registry last updated
- 2026-08-21
- Primary completion date
- 2026-12-01
- Start date
- 2024-06-27
- Actual participants
- 1,400
- Participants
- 1,400
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06468228
- ClinicalTrials.gov ID
- NCT06468228
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
Timeframe: 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.
Number of Participants with Adverse Events (AEs)
Timeframe: 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 Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
Timeframe: 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.
Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: At Week 16
Percentage of Participants Achieving HiSCR 90
Timeframe: 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)
Timeframe: At Week 8
Change from Baseline in HSSA
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: At Week 16
Change from Baseline in HSIA Mobility Domain
Timeframe: at Week 16
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 12 Years
- Healthy volunteers
- No
- 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
- Cahaba Dermatology & Skin Health Center /ID# 263795Birmingham, United States
- Medical Dermatology Specialists /ID# 263394Phoenix, United States
- Banner University Medicine Dermatology /ID# 263557Tucson, United States
- Dermatology Trial Associates /ID# 264587Bryant, United States
- Arkansas Research Trials /ID# 263901North Little Rock, United States
- Encino, United States
- Dermatology Research Associates - Los Angeles /ID# 263765Los Angeles, United States
- Stanford University School of Medicine - Redwood City /ID# 263711Redwood City, United States
- Norcal Clinical Research /ID# 279008Rocklin, United States
- Integrative Skin Science and Research /ID# 264600Sacramento, United States
- Clinical Trials Research Institute /ID# 263743Thousand Oaks, United States
- Yale University School of Medicine /ID# 263695New Haven, United States
- Clearlyderm Dermatology - West Boca /ID# 265023Boca Raton, United States
- Apex Clinical Trials /ID# 263815Brandon, United States
- TrueBlue Clinical Research - Brandon /ID# 265041Brandon, United States
- Florida Academic Dermatology Center /ID# 263834Coral Gables, United States
- Direct Helpers Research Center /ID# 278343Hialeah, United States
- Skin Care Research - Hollywood /ID# 263805Hollywood, United States
- Gsi Clinical Research /ID# 263827Margate, United States
- Sullivan Dermatology /ID# 263511Miami, United States
- Vitalia Medical Research /ID# 278321North Palm Beach, United States
- Renstar Medical Research - Ocala - Northeast 1st Avenue /ID# 263842Ocala, United States
- Skin Care Research - Tampa /ID# 263819Tampa, United States
- Advanced Clinical Research Institute - Tampa /ID# 263808Tampa, United States
- University of South Florida /ID# 269624Tampa, United States
And 254 more, listed on the interactive page.
Other registry identifiers
- 2024-510730-40-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Hidradenitis suppurativa Primary condition