Hidradenitis Suppurativa study: SAR445399
Official title A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07225569
What this study is testing
What is SAR445399?
An investigational injectable medicine being studied for moderate to severe hidradenitis suppurativa.
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
- The study will see if SAR445399 works and is safe for people with moderate to severe hidradenitis suppurativa. It compares two doses to a placebo.
- Who it's for
- Adults who have moderate to severe hidradenitis suppurativa.
- What's involved
- Participants will receive either SAR445399 or a placebo. They will have 16 visits for check‑ups, tests, and medication changes.
- Time commitment
- The study lasts up to 46 weeks, with 32 weeks of treatment and 16 visits in total.
- 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
- 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.
- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of...
- Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS
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 recurrent or recent serious infection
- Known history of or suspected current immunosuppression
- History of solid organ transplant or stem cell transplant.
- History of splenectomy
- History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was...
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
- 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.
- Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics or demonstrated intolerance to antibiotics or has a...
- Participants in the biologic-naïve stratum must be naïve to any prior use of biologic therapy with a potential impact on HS
- Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
- History of recurrent or recent serious infection
- Known history of or suspected current immunosuppression
- History of solid organ transplant or stem cell transplant.
- History of splenectomy
- History of malignancy or lymphoproliferative disease other than adequately treated or nonmetastatic squamous cell carcinoma of the skin that was excised and completely cured or nonmetastatic basal cell carcinoma of the...
- 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
- Scottsdale, Arizona, United States
- Boynton Beach, Florida, United States
- Fort Lauderdale, Florida, United States
- Fort Myers, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Cumming, Georgia, United States
- Fayetteville, Georgia, United States
- Skokie, Illinois, United States
- Evansville, Indiana, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- The Bronx, New York, United States
- Tulsa, Oklahoma, United States
- The Woodlands, Texas, United States
- Norfolk, Virginia, United States
- Buenos Aires, Argentina
- Sydney, New South Wales, Australia
+ 58 more site(s).
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 Scottsdale, Arizona, United States; Boynton Beach, Florida, United States; Fort Lauderdale, Florida, United States; Fort Myers, Florida, United States; Hollywood, Florida, United States; Miami, Florida, United States and 72 more locations. 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.