Actively Recruiting
A Seamless Phase 2a2b Randomized, Double-Blind, Placebo- and Active-Controlled Adaptive Study of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
Led by Almirall, S.A. · Updated on 2026-05-11
200
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different dosing schedules of LAD191 in adults with moderate-to-severe Hidradenitis Suppurativa HS. This phase 2 study aims to compare LAD191 with a placebo and adalimumab, focusing on how well the treatments work, their safety, tolerability, how the body processes the drug, and immune system responses. The study uses an adaptive design with interim data to assess whether to continue certain doses. Participants will undergo up to 4 weeks of screening before entering a 16-week double-blind, placebo-controlled treatment period Treatment Period 1. Then, all participants will receive LAD191 in a 16-week double-blind period Treatment Period 2. The study includes five groups three doses of LAD191, placebo during the first period then LAD191, or adalimumab during the first period then LAD191. After these treatment periods, there is a 12-week safety follow-up. During the study, participants will receive subcutaneous injections as per their assigned group. Researchers will assess the proportion of participants achieving significant reductions in HS lesions at week 16 using clinical response scores. Additional measures include skin pain levels and quality of life related to HS. Safety, tolerability, and other health evaluations will occur throughout the trial. Total participation spans screening, two treatment periods, and safety monitoring until study completion.
CONDITIONS
Brief Title
A Study of LAD191 in Adults With Hidradenitis Suppurativa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed with moderate-to-severe Hidradenitis Suppurativa with at least 5 inflammatory lesions
- HS lesions present in at least 2 different body areas, with at least one area at Hurley Stage II or III
- HS symptoms present for at least 6 months
- History of inadequate response, intolerance, or contraindication to systemic antibiotics for HS
- Regular use of over-the-counter topical antiseptics on HS lesions during the study
- Agreement to avoid pregnancy and exposure to LAD191 for women of child-bearing potential and male participants
You will not qualify if you...
- More than 20 draining tunnels at screening or baseline
- Current medical conditions requiring systemic immunosuppressive or immunomodulating treatments
- Known allergy to LAD191 or its ingredients
- Known allergy or contraindication to adalimumab or its biosimilars
- Significant hypersensitivity to prior biologic therapies
- Previous treatment with LAD191
- Live or attenuated vaccines within 4 weeks before baseline or planned during the study
- Pregnant or breastfeeding women, or planning pregnancy or breastfeeding during the study
- Use of prohibited medications or therapies without required washout before baseline
Research Team
V
Victor Castellano
E
Estrella García
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