A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Conditions

• Hidradenitis Suppurativa

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lutikizumab — DRUG
  Subcutaneous injection
• Placebo — DRUG
  Subcutaneous injection

Study Details

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.

Key Dates

Start date

Jun 27, 2024

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

1,400 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Period 1
  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 .
• Experimental: Period 2: Lutikizumab Every Week
  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
• Experimental: Period 2: Lutikizumab Every Other Week
  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
• Experimental: Period 2: Placebo to Lutikizumab Group
  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.
• Experimental: Period 2: Placebo to Lutikizumab Group Every Week
  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
• Experimental: Period 2: Placebo to Lutikizumab Group Every Other Week
  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
• Experimental: Period 3: Open-label Lutikizumab
  Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
• Experimental: Sub-Study: Lutikizumab Pre-Filled Pen
  Lutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75 [ Time Frame: At Week 16 ]

Locations (73)

Find similar trials in Birmingham, AL

Related Studies

• The Ohio State University Dermatology Biorepository
  Recruiting · Ohio State University · Columbus, Ohio
• Clinical and Biological Characteristics of Hidradenitis Suppurativa
  Recruiting · University of California, San Francisco · San Francisco, California
• Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
  Recruiting · University of California, San Francisco · San Francisco, California
• Battlefield Acupuncture for Pain in Hidradenitis Suppurativa
  Recruiting · Wayne State University · Dearborn, Michigan