LAD191 for adults with moderate-to-severe hidradenitis suppurativa

A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

This trial will try different doses of LAD191 to see if it reduces lesions and symptoms in adults with moderate-to-severe hidradenitis suppurativa compared with placebo and adalimumab.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Almirall, S.A. (Industry-sponsored)
• Drugs / interventions: adalimumab
• Locations: 1 site (Manises)
• Trial ID: NCT07151937 on ClinicalTrials.gov

What this trial studies

This is a randomized, adaptive Phase 2 trial testing multiple dosing regimens of LAD191 against placebo with an active adalimumab arm for context, using interim data to stop futile arms. The design includes up to 4 weeks of screening, a 16-week double-blind placebo-controlled treatment period, a subsequent 16-week LAD191 double-blind period, and a 12-week safety follow-up. Participants are randomized to one of three LAD191 dose levels, adalimumab, or placebo and will be monitored for efficacy, safety, pharmacokinetics, and immunogenicity. The adaptive interim analysis allows modification or early stopping of ineffective dosing arms.

Who should consider this trial

Good fit: Adults aged 18–65 with moderate-to-severe HS (≥5 inflammatory lesions, disease in ≥2 anatomical areas with at least one Hurley stage II or III) who have inadequate response or intolerance to systemic antibiotics and can follow study procedures and contraception rules are ideal candidates.

Not a fit: People with mild HS, those outside the 18–65 age range, patients who respond well to standard antibiotics, pregnant people, or those unable to attend the Manises site visits are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, LAD191 could reduce inflammatory lesions and improve symptoms for people with moderate-to-severe HS who have not responded well to antibiotics.

How similar studies have performed: Other biologic therapies such as adalimumab have shown benefit in HS, but LAD191 is a novel agent being tested and has not yet been proven in this condition.

Eligibility criteria

Inclusion Criteria:

* Aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 65 years.
* A diagnosis of moderate-to-severe HS defined as a total of \>= 5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline/Day 1 visits, with signs and symptoms of HS for at least 6 months.
* HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline/Day 1 visits.
* History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the screening visit.
* Regular use of over-the-counter topical antiseptics on HS lesions and agrees to regular use, throughout the entirety of the study.
* Participants who are women of child-bearing potential (WOBCP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD191 during the study.

Exclusion Criteria:

* HS with \>20 draining tunnels at the Screening or Baseline/Day 1 visit.
* Ongoing medical conditions requiring systemic immunosuppressive/immunomodulating treatments during the study.
* Known hypersensitivity to LAD191 or any of its excipients.
* Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved product information, and as per the Investigator's judgment.
* Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment.
* Prior treatment with LAD191.
* Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
* Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required washout period for a particular prohibited medication prior to Baseline/Day 1.

Where this trial is running

Manises

• Hospital de Manises — Manises, Spain (Recruiting)

Study contacts

• Study coordinator: Victor Castellano

Conditions Hidradenitis Suppurativa