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Can an injected drug calm the painful flares of hidradenitis suppurativa?

NCT ID NCT07812116

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing different doses of duvakitug, an injected drug, against placebo in adults with moderate to severe hidradenitis suppurativa. The trial enrolls about 156 people who have painful lumps and tunnels in at least two skin areas. Participants receive either duvakitug or placebo injections for up to 40 weeks, with some continuing longer. The main goal is to see whether the drug reduces abscess and inflammatory nodule counts by at least 75 percent.

What this could mean

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

Active substance
duvakitug, an experimental injectable drug
What this could lead to
If it works, duvakitug could become a new treatment option for people with moderate to severe hidradenitis suppurativa, a painful skin condition with few effective therapies.
What could go wrong
This is a mid-stage trial, so it may fail to show a clear benefit over placebo or cause side effects that outweigh any good. Results in this small group may not hold up in larger studies.

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 156 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

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 years and older

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: * Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 6 months prior to Baseline Visit * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left, and right axilla; or left axilla and left inguino-crural fold), with at least 1 body site being Hurley Stage II or III. * Participant must have a total abscess and inflammatory nodule (AN) count of ≥5 at the Baseline Visit. * Participants must have had an inadequate response to a course of a systemic antibiotics for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics, or has a contraindication to systemic antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history. * Participants must have a prior HS treatment history consistent with the following: * For the biologic and immunosuppressive small molecule-naïve subgroup, participants must have no history of treatment with any approved or investigational biologic therapy or small molecule immunosuppressive therapy with potential efficacy for HS. * For the biologic and immunosuppressive small molecule-experienced subgroup, participants must have a history of treatment with at least 1 biologic or immunosuppressive small molecule therapy with potential efficacy for HS. Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: * Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS. * History of systemic hypersensitivity or anaphylaxis to any biologic therapy * History of recurrent or recent serious infection * Known history of or suspected significant current immunosuppression * History of solid organ transplant or stem cell transplant. * History of splenectomy * History of malignancy or suspicion of malignancy within 5 years prior to the Screening Visit (except for in situ cervical carcinoma that has been treated by surgery and completely cured, or basal cell carcinoma or squamous cell carcinoma that has been excised and completely cured) * History within the 2 years prior to Baseline Visit of prescription drug or substance abuse, including alcohol, considered significant by the Investigator. * Any medical or psychiatric condition which, in the opinion of the Investigator could be considered uncontrolled, unstable, or likely to progress in a clinically relevant manner and may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments. * Any other medical condition or severe, concomitant illness, including psychiatric illness and substance abuse, that may present an unreasonable risk to the study participants, make participants unreliable, or may interfere with study assessments. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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 ↗

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Contacts and locations

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