A study to evaluate efficacy and safety of SAR441566 in adults with plaque psoriasis

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] - Immune System Diseases [C20]

Trial duration

25 Jan 2024 → 11 Dec 2024

Decision date (initial)

2024-01-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Research & Development

External identifiers

EU CT number

2023-503911-14-00

WHO UTN

U1111-1290-5787

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety, Dose response, Pharmacogenomic, Pharmacokinetic

To demonstrate the superiority of SAR441566 over placebo in participants with moderate to severe plaque psoriasis, in the Naïve Targeted Immunotherapy Population (NTIP)

Secondary objectives 3

1. To evaluate the efficacy of SAR441566 in plaque psoriasis as compared to placebo in the NTIP
2. To evaluate the safety of SAR441566
3. To assess pharmacokinetics of SAR441566 in participants with moderate to severe plaque psoriasis

Conditions and MedDRA coding

Psoriasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants with moderate to severe plaque psoriasis for at least 6 months, meeting the following criteria at screening and D1 (prior to randomization): • PASI ≥ 12 points; and • sPGA score ≥ 3 points; and • BSA score ≥ 10%,and D1 (prior to randomization): • PASI ≥ 12 points; and • sPGA score ≥ 3 points; and • BSA score ≥ 10%
2. Must be a candidate for phototherapy or systemic therapy.
3. Total body weight >= 50 kg (110 lb) and body mass index (BMI) within the range [18 – 35] kg/m2 (inclusive).

Exclusion criteria 14

1. Other forms of psoriasis than plaque psoriasis, such as guttate psoriasis, psoriatic arthritis, or pustular psoriasis. Nail psoriasis is accepted for inclusion.
2. Plaque psoriasis is restricted to scalp, palms, soles, or flexures only.
3. Any other skin diseases that can interfere with psoriasis evaluation or treatment response (eg, atopic dermatitis, fungal or bacterial superinfection).
4. Other immunologic (autoimmune or inflammatory) disorder, except medically controlled diabetes or thyroid disorder as per Investigator's judgement.
5. History of recurrent or recent serious infection (eg, pneumonia, septicemia), or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D1, or infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D1.
6. Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
7. Participant with personal or family history of long QT syndrome.
8. History of moderate to severe congestive heart failure (New York Heart Association Class III or IV), or recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol.
9. History of solid organ transplant.
10. History of alcohol or drug abuse within the past 2 years.
11. History of diagnosis of demyelinating disease such as but not limited to: • Multiple Sclerosis, • Acute Disseminated Encephalomyelitis, • Balo's Disease (Concentric Sclerosis), • Charcot-Marie-Tooth Disease, • Guillain-Barre Syndrome, • Human T-lymphotropic virus 1 Associated Myelopathy, • Neuromyelitis Optica (Devic's Disease).
12. Planned surgery during the treatment period.
13. Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
14. Any live (attenuated) vaccine within 6 weeks prior to randomization (eg, varicella zoster vaccine, oral polio, rabies) or plan to receive one during the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with a 75% or greater PASI score (Psoriasis Area and Severity Index score) improvement (reduction) from baseline (PASI75) at week 12

Secondary endpoints 5

1. PASI percent change from baseline to week 12
2. Proportion of participants with static Psoriasis Global Assessment (sPGA) score 0 (complete clearance) or 1 (minimal disease) at week 12
3. Number of participants with Treatment- Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
4. Plasma pre-dose concentrations of SAR441566
5. Plasma post-dose concentrations of SAR441566

Investigational products

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

Test 2

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 8

Locations

7 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 117 files

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

Application history

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