A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— HS OBTAIN  

Official title:

A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study Assessing the Efficacy and Safety of an Anti-TNF-OX40L NANOBODY® Molecule, SAR442970, in Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05849922
• Other study ID #: ACT16852
• Secondary ID: U1111-1280-64932
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 6, 2023
• Est. completion date: January 8, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study duration will be up to 40 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: January 8, 2025
• Est. primary completion date: August 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin that was excised and completely cured

• 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

• Laboratory exclusion criteria apply

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• SAR442970
1 mL extractable volume of 150 mg/mL SAR442970 filled in 2 mL glass vial
• Placebo
1 mL extractable volume of placebo filled in 2 mL glass vial

Locations

Country	Name	City	State
Australia	Investigational Site Number : 0360001	Carlton	Victoria
Australia	Investigational Site Number : 0360002	Liverpool	New South Wales
Australia	Investigational Site Number : 0360005	Westmead	New South Wales
Australia	Investigational Site Number : 0360003	Woolloongabba	Queensland
Belgium	Investigational Site Number : 0560001	Leuven
Belgium	Investigational Site Number : 0560002	Sint-Lambrechts-Woluwe
Canada	Investigational Site Number : 1240001	Barrie	Ontario
Canada	Investigational Site Number : 1240002	London	Ontario
Canada	Investigational Site Number : 1240004	Newmarket	Ontario
Canada	Investigational Site Number : 1240007	Quebec
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520002	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520003	Santiago	Reg Metropolitana De Santiago
Czechia	Investigational Site Number : 2030003	Ostrava - Poruba
Czechia	Investigational Site Number : 2030001	Praha 10
Czechia	Investigational Site Number : 2030002	Praha 5 - Motol
Denmark	Investigational Site Number : 2080001	Roskilde
France	Investigational Site Number : 2500001	Lyon
France	Investigational Site Number : 2500002	Nice
France	Investigational Site Number : 2500003	Reims
France	Investigational Site Number : 2500004	Saint Mande
Germany	Investigational Site Number : 2760005	Berlin
Germany	Investigational Site Number : 2760008	Bochum
Germany	Investigational Site Number : 2760002	Frankfurt am Main
Germany	Investigational Site Number : 2760004	Mainz
Germany	Investigational Site Number : 2760001	Münster
Greece	Investigational Site Number : 3000001	Athens
Greece	Investigational Site Number : 3000003	Athens
Italy	Investigational Site Number : 3800003	Catania
Italy	Investigational Site Number : 3800001	Milano	Lombardia
Italy	Investigational Site Number : 3800002	Rozzano	Lombardia
Netherlands	Investigational Site Number : 5280002	Breda
Netherlands	Investigational Site Number : 5280001	Groningen
Netherlands	Investigational Site Number : 5280003	Rotterdam
Poland	Investigational Site Number : 6160004	Lodz
Poland	Investigational Site Number : 6160001	Warszawa	Mazowieckie
Poland	Investigational Site Number : 6160002	Wroclaw
Poland	Investigational Site Number : 6160003	Wroclaw
Spain	Investigational Site Number : 7240003	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240005	Córdoba
Spain	Investigational Site Number : 7240006	Madrid	Madrid, Comunidad De
Spain	Investigational Site Number : 7240001	Madrid / Madrid	Madrid, Comunidad De
Spain	Investigational Site Number : 7240004	Manises	Valencia
Sweden	Investigational Site Number : 7520001	Alvsjo
United States	Center for Clinical Studies, LTD. LLP Site Number : 8400003	Houston	Texas
United States	Clinical Partners, LLC Site Number : 8400010	Johnston	Rhode Island
United States	Renstar Medical Research Site Number : 8400011	Ocala	Florida
United States	Medical Dermatology Specialists Site Number : 8400007	Phoenix	Arizona
United States	Advanced Medical Research PC Site Number : 8400002	Sandy Springs	Georgia
United States	ForCare Clinical Research Site Number : 8400006	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Chile,  Czechia,  Denmark,  France,  Germany,  Greece,  Italy,  Netherlands,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of biologic and small molecule immunosuppressive-naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)	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	Week 16
Secondary	Time to onset of achieving HiSCR50		Up to week 16
Secondary	Percentage of participants achieving HiSCR75 at 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	Week 16
Secondary	Percentage of participants achieving HiSCR90 at 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	Week 16
Secondary	Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16	The determination of IHS4 requires counting the inflammatory nodules, abscesses and draining tunnels and multiplying each by a specific coefficient	Week 16
Secondary	Change in absolute score from Baseline in IHS4 at week 16		From Baseline to week 16
Secondary	Percentage of participants who experience a flare	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.	Week 16
Secondary	Percentage of participants achieving IHS4-55	IHS4-55 is defined as achievement of a 55% reduction in IHS4 score from Baseline	Week 16
Secondary	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
Secondary	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	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)	Week 16
Secondary	Serum SAR442970 concentrations throughout the study		Up to 36 weeks
Secondary	Incidence of anti-SAR442970 antibody positive response throughout the study		Up to 36 weeks