Hidradenitis study: Duvakitug
Official title A Study to Investigate Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07812116
What this study is testing
What is Duvakitug?
Duvakitug is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hidradenitis.
Also referred to as SAR447189.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a parallel, Phase 2b, 3-arm, multinational, dose-ranging study to look at how well it works and the safety of different doses of duvakitug in adult people with moderate to severe hidradenitis suppurativa.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- 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...
- For the biologic and immunosuppressive small molecule-naïve subgroup, participants must have no history of treatment with any approved or...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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 how well it...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Miami, Florida, United States
- Peterborough, Ontario, Canada
- Richmond Hill, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Miami, Florida, United States; Peterborough, Ontario, Canada; Richmond Hill, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.