Hidradenitis Suppurativa
Conditions
Brief summary
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. The study duration (per participant) will be up to 46 weeks with a total of 16 visits. The treatment duration will be 32 weeks which includes 16-week double-blinded initial treatment period and a 16-week treatment-blinded extension period.
Interventions
DRUGSAR445399
Pharmaceutical form: Solution for injection -Route of administration: Injection
DRUGPlacebo
Pharmaceutical form: Solution for injection -Route of administration: Injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
\[Specify Complex Masking\]
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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-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 least one dose of biologic therapy for HS.
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) | Up to Week 16 | Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with TEAEs AESIs, and SAEs including administration site reactions during the double-blinded initial treatment period and the treatment-blinded extension period | Up to End of Study (approximately 46 weeks) | Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs). |
| Number of participants with potentially clinically significant abnormalities in laboratory tests, vital signs, and electrocardiograms (ECGs) during the double- blinded initial treatment period and the treatment-blinded extension period | Up to End of Study (approximately 46 weeks) | — |
| Plasma concentrations of SAR445399 during the double-blinded initial treatment period and the treatment-blinded extension period | Up to End of Study (approximately 46 weeks) | — |
| Incidence of anti-drug antibodies (ADA) of SAR445399 at prespecified timepoints during the double-blinded initial treatment period and the treatment-blinded extension period | Up to End of Study (approximately 46 weeks) | — |
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) | Up to Week 16 | Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) is defined as ≥50% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining tunnel count) |
| Absolute change from baseline to Week 16 in International Hidradenitis Suppurativa Severity Score System (IHS4) | 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. |
| Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90) | Up to Week 16 | Hidradenitis Suppurativa Clinical Response 90 is defined as ≥90% reduction from baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count. |
| Percent change from baseline to Week 16 in draining tunnel count | From Baseline to week 16 | — |
| Absolute change from baseline to Week 16 in draining tunnel count | From Baseline to week 16 | — |
| Percentage of participants with improvement from baseline to Week 16 of >=3 points in weekly average HS-Skin Pain NRS item 1a from HS-SAQ, among participants with baseline HS-Skin Pain NRS ≥3 | From baseline to Week 16 | The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (NRS) items assessing symptoms of HS. Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) is based on worst skin pain in a 24-hour recall period (daily assessment is averaged over 7-day period). |
| Percent change from baseline to Week 16 in Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) | From Baseline to Week 16 | — |
| Absolute change from baseline to Week 16 in the Dermatology Life Quality Index (DLQI) total score | From Baseline to Week 16 | The Dermatology Life Quality Index (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. |
| Absolute change from baseline to Week 16 in the total Hidradenitis Suppurativa Quality of Life (HiSQoL) score | From Baseline to Week 16 | The Hidradenitis Suppurativa Quality of Life (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. |
| Change from baseline to Week 16 in Weekly average HS-SAQ score items | From Baseline to Week 16 | The Hidradenitis Suppurativa Symptom Assessment Questionnaire (HS-SAQ) is a 7-item scale comprising unidimensional numeric rating scale (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". |
| Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16 | From Baseline to Week 16 | The Peak Pruritus Numerical Rating Scale (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) |
| Change from baseline to Week 16 in the Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) total score | From Baseline to Week 16 | The Hidradenitis Suppurativa Impact Assessment Questionnaire (HS-IAQ) is an 11-item questionnaire assessing the impact of HS on QoL |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Spain, Sweden, Turkey (Türkiye), United States
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed