A Phase 2 study to evaluate the efficacy and safety of SAR444656 compared with placebo in adult participants with moderate to severe hidradenitis suppurativa.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

27 Dec 2023 → 12 Nov 2025

Decision date (initial)

2023-11-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Développement

External identifiers

EU CT number

2023-504328-25-00

WHO UTN

U1111-1285-8790

ClinicalTrials.gov

NCT06028230

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Efficacy, Pharmacodynamic, Dose response, Safety, Pharmacogenetic

To evaluate clinical efficacy of SAR444656 in participants with moderate to severe hidradenitis suppurativa (HS) based on the reduction of abscess and inflammatory nodule (AN) count at Week 16.

Secondary objectives 4

1. To evaluate clinical efficacy of SAR444656 in participants with moderate to severe HS as measured by other clinical assessments
2. To evaluate the effect of SAR444656 on pain in participants with HS
3. To evaluate the safety of SAR444656 in participants with HS
4. To evaluate the pharmacokinetic profile of SAR444656 in adult participants with HS

Conditions and MedDRA coding

hidradenitis suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
2. 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.
3. Participant must have had an inadequate response after at least one-month of oral antibiotic treatment for HS as assessed by the Investigator
4. Participant must have a total AN count of ≥5 at the baseline visit.
5. Participant must have a draining tunnel count of ≤20 at the baseline visit.
6. Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol.
7. 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 15

1. Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
2. 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.
3. 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.
4. Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
5. Participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite antihypertensive medication.
6. Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
7. Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
8. 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.
9. Participant with history of solid organ transplant.
10. Participant with history of splenectomy.
11. 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.
12. Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS
13. Participant with family history of sudden death or long QT syndrome.
14. Participant with history of congenital or drug-induced long QT syndrome.
15. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline in total abscess and inflammatory nodule (AN) count

Secondary endpoints 10

1. Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50)
2. Proportion of participants achieving AN count ≤2
3. Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
4. Proportion of participants with improvement from baseline in Hurley Stage
5. Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline)
6. Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS)
7. Proportion of participants achieving improvement defined as at least 30% redaction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS
8. Change from baseline in the amount of analgesic
9. 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
10. Plasma SAR444656 concentration

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Research & Development

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Research & Development

Contact name

Clinical Sciences and Operations

Third parties 6

Locations

4 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Unexpected events 1 · Art. 53 CTR

Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 87 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications