NCT07151937 A Study of LAD191 in Adults With Hidradenitis Suppurativa
| NCT ID | NCT07151937 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Almirall, S.A. |
| Condition | Hidradenitis Suppurativa |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-05-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-11-05 with a primary completion date of 2027-05-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of this study is to assess the efficacy of multiple dosing regimens of LAD191 compared to 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.
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.
Contact & Investigator
Study Director
STUDY DIRECTOR
Almirall, S.A.
Frequently Asked Questions
Who can join the NCT07151937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hidradenitis Suppurativa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07151937 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07151937 currently recruiting?
Yes, NCT07151937 is actively recruiting participants. Contact the research team at gco@almirall.com for enrollment information.
Where is the NCT07151937 trial being conducted?
This trial is being conducted at Manises, Spain.
Who is sponsoring the NCT07151937 clinical trial?
NCT07151937 is sponsored by Almirall, S.A.. The principal investigator is Study Director at Almirall, S.A.. The trial plans to enroll 200 participants.