Clinical trial NCT06028230: A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Kymera Therapeutics, Inc.
First posted: 2023-09-08
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel, Phase 2, 3-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


Eligibility criteria: 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 after at least one-month of oral antibiotic treatment for 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 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.

Primary outcomes:
measure: Percent change from baseline in total abscess and inflammatory nodule (AN) count
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)
timeFrame: Week 16
measure: Proportion of participants achieving AN count ≤2
timeFrame: Week 16
measure: Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
timeFrame: Week 16
measure: Proportion of participants with improvement from baseline in Hurley Stage
timeFrame: Week 16
measure: Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)
timeFrame: Week 16
measure: Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Change from baseline in the amount of analgesic
timeFrame: Up to Week 16
measure: 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
timeFrame: Up to Week 20
measure: Plasma SAR444656 concentration
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center Scottsdale Site Number : 8400006
state: Arizona
city: Anaheim
country: United States
facility: Cosmetic Dermatology of Orange County- Site Number : 8400024
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Site Number: 8400007
state: California
city: San Diego
country: United States
facility: Paradigm Clinical Research - San Diego - ClinEdge - PPDS- Site Number : 8400021
state: California
city: Boynton Beach
country: United States
facility: Encore Medical Research - Boyton Beach Site Number : 8400002
state: Florida
city: Brandon
country: United States
facility: TrueBlue Clinical Research - Brandon - HyperCore - PPDS Site Number : 8400001
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research Site Number : 8400005
state: Florida
city: North Miami Beach
country: United States
facility: Tory Sullivan, MD, PA Site Number: 8400003
state: Florida
city: Weston
country: United States
facility: Encore Medical Research Site Number: 8400010
state: Florida
city: Clarksville
country: United States
facility: Dermatology Specialists Research - 3810 Springhurst Blvd Site Number : 8400012
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group LLC Site Number : 8400011
state: Indiana
city: Dearborn
country: United States
facility: Wayne Health-Dearborn Site Number : 8400004
state: Michigan
city: Troy
country: United States
facility: Revive Research Institute-1575 W Big Beaver Rd Site Number : 8400008
state: Michigan
city: Camp Hill
country: United States
facility: Vial Health - DermDox Dermatology- Site Number : 8400020
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-3601 5th Ave Site Number : 8400009
state: Pennsylvania
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane- Site Number : 8400015
state: Washington
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Las Condes
country: Chile
facility: Investigational Site Number : 1520001
city: Temuco
country: Chile
facility: Investigational Site Number : 1520004
city: Heidelberg
country: Germany
facility: Investigational Site Number : 2760002
state: Baden-Württemberg
city: München
country: Germany
facility: Investigational Site Number : 2760008
state: Bayern
city: Würzburg
country: Germany
facility: Investigational Site Number : 2760006
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Investigational Site Number : 2760007
state: Hessen
city: Bochum
country: Germany
facility: Investigational Site Number : 2760001
state: Nordrhein-Westfalen
city: Remscheid
country: Germany
facility: Investigational Site Number : 2760004
state: Nordrhein-Westfalen
city: Dessau-Roßlau
country: Germany
facility: Investigational Site Number : 2760009
state: Sachsen-Anhalt
city: Berlin
country: Germany
facility: Investigational Site Number : 2760005
city: Athens
country: Greece
facility: Investigational Site Number : 3000003
state: Attiki
city: Pavlos Melas
country: Greece
facility: Investigational Site Number: 3000001
state: Thessaloniki
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160006
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Investigational Site Number : 6160002
state: Dolnośląskie
city: Lódz
country: Poland
facility: Investigational Site Number : 6160005
state: Lódzkie
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160003
state: Mazowieckie
city: Ossy
country: Poland
facility: Investigational Site Number : 6160004
state: Slaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160007
city: Cadiz
country: Spain
facility: Investigational Site Number : 7240004
state: Cádiz
city: Manises
country: Spain
facility: Investigational Site Number : 7240005
state: Valencia
city: Alicante
country: Spain
facility: Investigational Site Number : 7240003
city: Granada
country: Spain
facility: Investigational Site Number : 7240001
city: Sevilla
country: Spain
facility: Investigational Site Number : 7240002
Study officials:
References: