LAD191 for adults with moderate-to-severe hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital de Manises
  Manises, Spain Recruiting

Study contacts

• Study coordinator: Victor Castellano
• Email: gco@almirall.com
• Phone: +34932746671

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• LAD328 in adults with hidradenitis suppurativa

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• Long-term real-world tracking of secukinumab treatment for moderate to severe hidradenitis suppurativa in Italy

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• Secukinumab outcomes in Canadians with hidradenitis suppurativa

  It will see how well secukinumab works and how safe it is for adults in Canada with moderate-to-severe hidradenitis suppurativa who were newly prescribed it in routine care.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.