HS OBTAIN: A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
Study Details
Study Description
Brief Summary
This is a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study is to evaluate the efficacy and safety of SAR442970 compared to placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The study duration will be up to 40 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SAR442970 Participants will receive SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Week 16 to Week 28). |
Drug: SAR442970
1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial
|
| Placebo Comparator: Placebo Participants will receive placebo Q2W in Period A (Day 1 to Week 16). Participants will receive SAR442970 Q2W in Period B (Week 16 to Week 28). |
Drug: Placebo
1 mL extractable volume of placebo filled in 2 mL glass vial
|
Outcome Measures
Primary Outcome Measures
- Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) [Week 16]
HiSCR50 is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
Secondary Outcome Measures
- Time to onset of achieving HiSCR50 [Up to week 16]
- Percentage of participants achieving HiSCR75 at Week 16 [Week 16]
HiSCR75 is defined as at least a 75% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
- Percentage of participants achieving HiSCR90 at week 16 [Week 16]
HiSCR90 is defined as at least a 90% reduction from Baseline in the total abscess and inflammatory nodule [AN] count, with no increase from Baseline in abscess or draining tunnel count
- Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16 [Week 16]
The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient
- Change in absolute score from Baseline in IHS4 at week 16 [From Baseline to week 16]
- Percentage of participants who experience a flare [Week 16]
Flare is defined as at least 25% increase in the total abscess and inflammatory nodule [AN] count (with a minimum increase of 2) relative to Baseline at week 16.
- Percentage of participants achieving IHS4-55 [Week 16]
IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from Baseline
- Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions [Up to week 36]
- Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from Baseline in weekly average of daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-SkinPainNRS) at Week 16 among participants with Baseline NRS ≥3 [Week 16]
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)
- Serum SAR442970 concentrations throughout the study [Up to 36 weeks]
- Incidence of anti-SAR442970 antibody positive response throughout the study [Up to 36 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants with a history of signs and symptoms consistent with hidradenitis suppurativa (HS) for at least 1 year 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 inguinocrural fold), one of which must be Hurley Stage II or Hurley Stage III.
-
Participant must have had an inadequate response to a trial of an oral antibiotic for treatment of HS, exhibited recurrence after discontinuation of antibiotics, 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 must be either biologic and small molecule immunosuppressive-naïve or TNF-experienced.
-
Participant must have a total abscess and inflammatory nodule (AN) count of ≥3 at the Baseline visit.
-
Participant must have a draining tunnel count of ≤20 at the Baseline visit.
-
Participant must have a C-reactive protein (CRP) >3 mg/L at the screening visit.
-
Participant who is a candidate for systemic treatment per Investigator's judgment.
Exclusion Criteria:
-
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 significant current immunosuppression
-
History of solid organ transplant
-
History of splenectomy
-
History of moderate to severe congestive heart failure
-
Receipt of a live vaccine 12 week prior to Baseline visit or receipt of a killed vaccine 2 weeks prior to Baseline visit
-
History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
-
Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin
-
Participants with a diagnosis of inflammatory conditions other than HS
-
Presence of active suicidal ideation, or positive suicide behavior or participant has a lifetime history of suicide attempt, or participant has had suicidal ideation in the past 6 months as indicated by a positive response using the screening or Baseline version of the Columbia-Suicide Severity Rating Scale (C-SSRS) or as assessed by the Investigator through participant interview and review of medical history
-
A history of an adverse event (AE) to anti-TNF therapy (examples include, but are not limited, to serum sickness or anaphylaxis) for an HS or non-HS indication that would contraindicate readministration of an anti-TNF class therapy
-
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
-
Female participants who are breastfeeding or considering becoming pregnant during the study
-
History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ACT16852
- U1111-1280-6493
- 2022-502370-17-00