First-in-human study of SAR447971

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human program with three parts: SAD20411 (single ascending dose with a pilot food effect) and MAD20412 (multiple ascending doses) in healthy adults, and MAD24339 (open-label, multiple ascending doses) in participants with hidradenitis suppurativa. SAD20411 and MAD20412 are double-blind, randomized, placebo-controlled studies at a single center, designed to assess safety and pharmacology, with sequential dose escalation. MAD24339 assesses safety and tolerability in HS patients with specific disease activity criteria. Overall enrollment targets are about 102 healthy volunteers and 20 HS participants, with study durations up to about 10 weeks for the healthy cohorts and up to about 12 weeks for the HS cohort.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

For participation in SAD20411/MAD20412:

Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female) or signs of acute illness. Active or chronic infection requiring systemic treatment within 4 weeks prior to baseline. Known history of immunosuppression or suspected current immunosuppression.

For participation in MAD24339:

* 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 therapies with potential therapeutic impact on HS \<28 days or five half-lives prior to baseline visit.
* 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 participation in a clinical trial.

Where it's running

• Investigational Site Number: 5280001
  Leiden, Netherlands Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.