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Tests treatment safety and results for Hidradenitis Suppurativa
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?
SAR445399 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for 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
- This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis suppurativa. The purpose of this study is to assess the efficacy and safety of two doses of SAR445399 compared with placebo in adult participants 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 are eligible to be included in the study only if all of the following criteria apply:
- 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...
- 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...
You likely can't join if
- 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 recurrent or recent serious infection
- Known history of or suspected current immunosuppression
- History of solid organ transplant or stem cell transplant.
- History of splenectomy
See the full eligibility criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 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; Participants in the biologic-experienced stratum must have documented history of use of at...
- 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 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's taking place
- Scottsdale, Arizona, United States
- North Hollywood, California, 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
- Overland Park, Kansas, United States
- Louisville, Kentucky, United States
- New York, New York, United States
- The Woodlands, Texas, United States
- Buenos Aires, Argentina
- Sydney, New South Wales, Australia
- Brussels, Belgium
- Ghent, Belgium
- Liège, Belgium
- Salvador, Estado de Bahia, Brazil
+ 40 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 - 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?
Study sites include Scottsdale, Arizona, United States; North Hollywood, California, United States; Boynton Beach, Florida, United States; Fort Lauderdale, Florida, United States; Fort Myers, Florida, United States; Hollywood, Florida, United States and 54 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.