A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— ZEN  

Official title:

A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028230
• Other study ID #: ACT17841
• Secondary ID: 2023-504328-25U1
• Status: Recruiting
• Phase: Phase 2
• Start date: September 29, 2023
• Est. completion date: March 14, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 8006331610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a parallel, Phase 2, 2-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years.

Study details include:

• Screening period: up to 4 weeks (30 days)

• Treatment duration: up to 16 weeks

• Follow-up period: up to 4 weeks

• Total study duration: up to 24 weeks

• Number of visits: 14

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: March 14, 2025
• Est. primary completion date: February 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.

• Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III.

• Participant must have had an inadequate response to at least a 3-month treatment of an oral antibiotic for treatment of HS as assessed by the Investigator.

• Participant must have a total AN count of =5 at the baseline visit.

• Participant must have a draining tunnel count of =20 at the baseline visit.

• Participant must have a CRP >3 mg/L obtained at screening.

• Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol.

• Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

• Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) 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.

• Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.

• Participant with history of solid organ transplant.

• Participant with history of splenectomy.

• Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for =5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed.

• Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS

• Participant with family history of sudden death or long QT syndrome.

• Participant with history of congenital or drug-induced long QT syndrome.

• Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.

• Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.

• Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.

• Participant with uncontrolled hypertension defined as consistent systolic blood pressure =150 mmHg or consistent diastolic blood pressure =90 mmHg despite antihypertensive medication.

• Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.

• Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17 therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study population. Furthermore, this 20% of biologic-experienced participants must fulfilled one or more of the following conditions:

• Discontinued due to treatment related toxicity and/or

• Discontinuation is not related to lack or loss of therapeutic response.

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• SAR444656 (KT-474)
Oral Tablet
• Placebo
Oral Tablet

Locations

Country	Name	City	State
Germany	Investigational Site Number : 2760001	Bochum	Nordrhein-Westfalen
Germany	Investigational Site Number : 2760009	Dessau-Roßlau	Sachsen-Anhalt
Germany	Investigational Site Number : 2760007	Frankfurt am Main	Hessen
Germany	Investigational Site Number : 2760002	Heidelberg	Baden-Württemberg
Germany	Investigational Site Number : 2760008	München	Bayern
Germany	Investigational Site Number : 2760004	Remscheid	Nordrhein-Westfalen
Germany	Investigational Site Number : 2760006	Würzburg	Bayern
Greece	Investigational Site Number : 3000003	Athens	Attiki
Greece	Investigational Site Number: 3000001	Pavlos Melas	Thessaloniki
Greece	Investigational Site Number : 3000002	Thessaloniki
Poland	Investigational Site Number : 6160005	Lódz	Lódzkie
Poland	Investigational Site Number : 6160004	Ossy	Slaskie
Poland	Investigational Site Number : 6160001	Ostrowiec Swietokrzyski	Swietokrzyskie
Poland	Investigational Site Number : 6160003	Warszawa	Mazowieckie
Poland	Investigational Site Number : 6160002	Wroclaw	Dolnoslaskie
Spain	Investigational Site Number : 7240003	Alicante
Spain	Investigational Site Number : 7240004	Cadiz	Cádiz
Spain	Investigational Site Number : 7240001	Granada
Spain	Investigational Site Number : 7240005	Manises	Valencia
Spain	Investigational Site Number : 7240002	Sevilla
United States	Encore Medical Research - Boyton Beach Site Number : 8400002	Boynton Beach	Florida
United States	TrueBlue Clinical Research - Brandon - HyperCore - PPDS Site Number : 8400001	Brandon	Florida
United States	Dermatology Specialists Research - 3810 Springhurst Blvd Site Number : 8400012	Clarksville	Indiana
United States	Wayne Health-Dearborn Site Number : 8400004	Dearborn	Michigan
United States	First OC Dermatology Site Number: 8400007	Fountain Valley	California
United States	Encore Medical Research Site Number : 8400005	Hollywood	Florida
United States	Dawes Fretzin Clinical Research Group LLC Site Number : 8400011	Indianapolis	Indiana
United States	Tory Sullivan, MD, PA Site Number: 8400003	North Miami Beach	Florida
United States	Clear Dermatology & Aesthetics Center Scottsdale Site Number : 8400006	Scottsdale	Arizona
United States	Revive Research Institute-1575 W Big Beaver Rd Site Number : 8400008	Troy	Michigan
United States	Encore Medical Research Site Number: 8400010	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Kymera Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in total abscess and inflammatory nodule (AN) count	The AN count is the sum of the abscess count and inflammatory nodule count at any given clinical assessment. It is derived from the lesion counts count obtained as part of the HS clinical parameters.	Week 16
Secondary	Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)		Week 16
Secondary	Proportion of participants achieving AN count =2		Week 16
Secondary	Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)		Week 16
Secondary	Proportion of participants with improvement from baseline in Hurley Stage		Week 16
Secondary	Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)		Week 16
Secondary	Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)		Week 16
Secondary	Proportion of participants achieving improvement defined as at least 30% reduction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS		Week 16
Secondary	Change from baseline in the amount of analgesic		Up to Week 16
Secondary	Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs		Up to Week 20
Secondary	Plasma SAR444656 concentration		Up to Week 16