Phase 2: testing LAD191 for Hidradenitis Suppurativa
The main purpose of this study is to assess the how well it works of multiple dosing regimens of LAD191 compared to dummy treatment (placebo) in participants with moderate-to-severe Hidradenitis Suppurativa (HS) and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.
Official registry: https://clinicaltrials.gov/study/NCT07151937 · Almirall, S.A. · enrollment listed as 200
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are LAD191, Placebo, or Adalimumab. The registry lists allocation as randomized. The main purpose of this study is to assess the how well it works of multiple dosing regimens of LAD191 compared to dummy treatment (placebo) in participants with moderate-to-severe Hidradenitis Suppurativa (HS) and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.
They plan to enroll about 200 people at Manises. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: LAD191, Placebo, Adalimumab
Primary outcome (registry wording): Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50)
Who it is for (from inclusion criteria)
- Ages 18 Years to 65 Years
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
Victor Castellano
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Hospital de Manises — Manises, Spain (recruiting)
FAQ about this NCT record
Is NCT07151937 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07151937?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07151937?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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