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New treatment option for Hidradenitis
Official title SAR447971 First-in-human Study
ClinicalTrials.gov ID: NCT07629336
What this study is testing
What is SAR447971?
SAR447971 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hidradenitis.
Also referred to as KT-485.
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
- SAD20411 is a single-center, first-in-human, double-blind, randomized, placebo-controlled, sequential single ascending dose study in healthy male and/or female participants with a pilot food effect investigation. MAD20412 is a single-center, double-blind, randomized, placebo-controlled, sequential multiple ascending dose study in healthy male and/or female participants.
- Phase 1: an early, usually small safety study
- 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 to 65. Healthy volunteers may be eligible.
You may be able to join if
- For participation in SAD20411/MAD20412:
- Male and/or female participant, between 18 and 55 years of age, inclusive at the time of signing the ICF.
- Appearing healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). For participation in MAD24339:
- Age ≥18 and ≤65 years of age at the time of signing informed consent.
- A diagnosis of HS made by a dermatologist at least 6 months prior to baseline visit.
You likely can't join if
- For participation in SAD20411/MAD20412: \- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic...
- Any active skin disease or condition other than HS (including but not limited to inflammatory skin diseases and cutaneous infections) that may...
- Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to...
- Use of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit. - Treatment with systemic antibiotics for...
- Any history of prior treatment with any systemic biologic with a potential therapeutic impact on HS. The above information is not intended to contain...
See the full eligibility criteria
- For participation in SAD20411/MAD20412:
- Male and/or female participant, between 18 and 55 years of age, inclusive at the time of signing the ICF.
- Appearing healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). For participation in MAD24339:
- Age ≥18 and ≤65 years of age at the time of signing informed consent.
- A diagnosis of HS made by a dermatologist at least 6 months prior to baseline visit.
- HS lesions present in at least 2 distinct anatomic areas (e. g., left and right axilla; or left axilla and left inguino-crural fold), one of which must be Hurley Stage II or Hurley Stage III.
- Total AN count of ≥4 at the baseline visit. - Draining tunnel count of ≤20 at the baseline visit.
- For participation in SAD20411/MAD20412: \- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular...
- Any active skin disease or condition other than HS (including but not limited to inflammatory skin diseases and cutaneous infections) that may interfere with assessment of HS.
- Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
- Use of prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit. - Treatment with systemic antibiotics for HS within 14 days prior to the baseline visit. - Non-biologic systemic...
- Any history of prior treatment with any systemic biologic with a potential therapeutic impact on HS. The above information is not intended to contain all considerations relevant to a participant's potential...
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, Netherlands
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 to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, Netherlands. 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.