NIPH Clinical Trials Search

A study to investigate efficacy and safety with SAR445399 in adult participants with moderate to severe hidradenitis suppurativa

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hidradenitis suppurativa
Date of first enrollment	06/03/2026
Target sample size	144
Countries of recruitment	United States,Japan
Study type	Interventional
Intervention(s)	Drug: SAR445399 Pharmaceutical form: Solution for injection/infusion, Route of administration: Injection/infusion Drug: Placebo Pharmaceutical form: Solution for injection, Route of administration: Injection/infusion Study Arms: Experimental: SAR445399 dose regimen A - Participants will receive SAR445399 dose regimen A. - - Interventions: SAR445399 Experimental: SAR445399 dose regimen B - Participants will receive SAR445399 dose regimen B. - - Interventions: SAR445399 Placebo Comparator: Placebo - Participants will receive SAR445399-matching placebo. - - Interventions: Placebo

Outcome(s)

Primary Outcome

1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Time Frame: Up to Week 16] HiSCR75 is defined as >=75% reduction from baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count.

Secondary Outcome

1. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Time Frame: Up to Week 16] HiSCR50 is defined as >=50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count. 2. Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4) [Time Frame: From baseline to Week 16] The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient. A high score signifies severe disease. 3. Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) [Time Frame: Up to Week 16] HiSCR90 is defined as >=90% reduction from baseline in the total AN count, with no increase from Baseline in abscess or draining tunnel count. 4. Percent change from baseline to Week 16 in draining tunnel count [Time Frame: From baseline to Week 16] 5. Absolute change from baseline to Week 16 in draining tunnel count [Time Frame: From baseline to Week 16] 6. Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) item 1 from Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ), among participants with baseline HS-Skin Pain NRS >=3 [Time Frame: From baseline to Week 16] The HS-SAQ is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. HS-Skin Pain NRS is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period). 7. Percent change from baseline to Week 16 in HS-Skin Pain NRS [Time Frame: From baseline to Week 16] 8. Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) score [Time Frame: From baseline to Week 16] The DLQI is a 10-item dermatology specific health related quality of life (HRQoL) instrument. Total score ranges from 0 to 30, with higher scores indicating greater detrimental impact on QoL. 9. Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score [Time Frame: From baseline to Week 16] The HiSQoL is a 17-item content-validated questionnaire with a 7-day recall period. It is scored by summing items to create a total score (0 to 68) with higher score indicating more severe impact on QoL. 10. Change from baseline to Week 16 in Weekly average HS-SAQ score items [Time Frame: From baseline to Week 16] The HS-SAQ is a 7-item scale comprising unidimensional NRS items assessing symptoms of HS. Each item is scored on a 0 to 10 scale with 0 indicating "no symptom" and 10 indicating "worst symptom possible". 11. Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) score [Time Frame: From baseline to Week 16] The HS-IAQ is an 11-item questionnaire assessing the impact of HS on QoL. 12. Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16 [Time Frame: From baseline to Week 16] The PP-NRS is defined as achieving at least 4-unit reduction from Baseline in weekly average of daily PP-NRS among participants with baseline PP-NRS >=4. 13. Number of participants with Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) including administration site reactions [Time Frame: Up to End of Study (approximately 30 weeks)] 14. Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs) [Time Frame: Up to End of Study (approximately 30 weeks)] 15. Serum concentrations of SAR445399 throughout the study [Time Frame: Up to End of Study (approximately 30 weeks)] 16. Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints [Time Frame: Up to End of Study (approximately 30 weeks)]

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 contraindication to oral antibiotics for treatment of their HS as assessed by the Investigator through participant interview and review of medical history. - Participants in the biologic-naive stratum must be naive 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 least one dose of biologic therapy for HS.
Exclude criteria	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 skin that was excised and completely cured. - 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 interfere with study assessments. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.