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New hope for HS sufferers: LAD191 enters Mid-Stage trial

NCT ID NCT07151937

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new injectable drug called LAD191 in 200 adults with moderate-to-severe hidradenitis suppurativa (HS), a painful skin condition causing abscesses and scarring. Participants will receive either LAD191, a placebo, or an active comparator (adalimumab) to see if LAD191 reduces skin lesions by at least 50% over 16 weeks. The goal is to find a more effective treatment for HS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LAD191 (injected under the skin)
What this could lead to
If successful, LAD191 could offer a new treatment option to reduce painful abscesses and nodules in people with hidradenitis suppurativa.
What could go wrong
This is an early Phase 2 study with only 200 participants. The drug may not work better than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital de Manises

    RECRUITING

    Manises, 46940, Spain

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