Can an injected drug calm the painful flares of hidradenitis suppurativa?
NCT ID NCT07812116
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Nanobody drug tested against painful skin condition
- Can a mediterranean diet tame hidradenitis suppurativa?
- Can we predict the path of chronic skin disease?
- Can a pill that degrades IRAK4 tame autoimmune inflammation?
- Could childhood trauma fuel skin inflammation?
- Head-to-Head: which pill tames hidradenitis suppurativa best?