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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,280
Subcutaneous injection
Subcutaneous injection
Cahaba Dermatology & Skin Health Center /ID# 263795
Birmingham, Alabama, United States
RECRUITINGMedical Dermatology Specialists /ID# 263394
Phoenix, Arizona, United States
RECRUITINGBanner University Medicine Dermatology /ID# 263557
Tucson, Arizona, United States
RECRUITINGDermatology Trial Associates /ID# 264587
Bryant, Arkansas, United States
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.
Time frame: 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.
Time frame: Up to Approximately Week 62
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.
Time frame: At Week 8
Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: At Week 16
Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline
Time frame: 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.
Time frame: At Week 16
Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 16
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain
Time frame: At Week 16
Change from Baseline in HSIA Mobility Domain
Time frame: at Week 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Arkansas Research Trials /ID# 263901
North Little Rock, Arkansas, United States
RECRUITINGPrivate Practice - Dr. Tooraj Raoof /ID# 263756
Encino, California, United States
RECRUITINGNorCal Medical Research /ID# 279008
Greenbrae, California, United States
RECRUITINGDermatology Research Associates - Los Angeles /ID# 263765
Los Angeles, California, United States
RECRUITINGStanford University School of Medicine - Redwood City /ID# 263711
Redwood City, California, United States
RECRUITINGIntegrative Skin Science and Research /ID# 264600
Sacramento, California, United States
RECRUITING...and 265 more locations