Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis and Anti-TNFα Inadequate Response

Official title

A Phase 3, Parallel-group, Randomized, Double-blind, 4-arm, Placebo-controlled, Multicenter Study With Risankizumab as Active Reference Arm, to Investigate the Efficacy and Safety of Subcutaneous Sonelokimab in Male and Female Participants Aged 18 Years and Over With Active Psoriatic Arthritis and Previous Inadequate Response or Intolerance to Tumor Necrosis Factor-α Inhibitors

Overview

This is a study to confirm the clinical efficacy and safety of sonelokimab compared with placebo in the treatment of adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Detailed description

M1095-PSA-302 is a Phase 3, parallel-group, randomized, double-blind, 4-arm, placebo-controlled, multicenter study with risankizumab as active reference arm to investigate the efficacy and safety of sonelokimab 60 mg and 120 mg versus placebo in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumor necrosis factor (TNF)α therapy.

Interventions

• Drug Sonelokimab
  Sonelokimab
• Drug Placebo
  Placebo
• Drug Risankizumab
  Active comparator

Primary outcome measures

• Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) [Time frame: Week 16 compared to placebo]

Secondary outcome measures (6)

• Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20) [Time frame: Week 16 compared to placebo]
• Response rate of participants achieving Minimal Disease Activity (MDA) [Time frame: Week 16 compared to placebo]
• Health Assessment Questionnaire- Disability Index (HAQ-DI) [Time frame: Week 16 compared to placebo]
• Psoriasis Area and Severity Index (PASI90) [Time frame: Week 16 compared to placebo]
• Short- form-36 (SF-36) Physical Component Summary (PCS) [Time frame: Week 16 compared to placebo]
• Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) [Time frame: Week 16 compared to risankzumab]

Eligibility criteria

Inclusion criteria

• Participants must be ≥18 years of age .
• Participants have a confirmed diagnosis of psoriatic arthritis (PsA) per the 2006 Classification for Psoriatic Arthritis (CASPAR) criteria with symptoms for ≥6 months before the Screening Visit.
• Participants have active disease (defined by a 68 tender joint count \[TJC68\] of ≥3 and a 66 swollen joint count \[SJC66\] of ≥3).
• Participants have current active plaque psoriasis (PsO) or a dermatologist-confirmed history of plaque PsO.
• Participants test negative for both rheumatoid factor and anti-cyclic citrullinated peptide at the Screening Visit.
• Participants must have received 1 or more TNFα inhibitors for PsA or PsO and must have experienced an inadequate response to treatment with at least one TNFα inhibitor(s) given at an approved dose for ≥3 months or have stopped treatment due to safety/tolerability problems after ≥1 administration of a TNFα inhibitor.

Exclusion criteria

• Participants with a known hypersensitivity to sonelokimab or any of its excipients.
• Participants with a known hypersensitivity, or any contraindication, to risankizumab or any of its excipients or component of the container.
• Participants who have a diagnosis of chronic inflammatory conditions other than PsO or PsA.
• Participants with a diagnosis of inflammatory bowel disease.
• Participants who have experienced a period of ≥3 consecutive weeks of unexplained diarrhea in the 24 weeks before the Baseline Visit.
• Participants who have an established diagnosis of arthritis mutilans.
• Previous exposure to sonelokimab.
• Participants who have ever received biologic immunomodulating agents for PsA or PsO whether investigational or approved, except for those targeting TNFα

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 44 centers

• Clinical Site — Avondale
• Clinical Site — Chandler
• Clinical Site — Flagstaff
• Clinical Site — Mesa
• Clinical Site — Phoenix
• Clinical Site — Scottsdale
• Clinical Site — Tucson
• Clinical Site — Jonesboro
• … and 36 more centers

Poland · 26 centers

Center list to be confirmed — check the primary protocol.

Spain · 13 centers

Center list to be confirmed — check the primary protocol.

Bulgaria · 11 centers

• Clinical Site — Pazardzhik
• Clinical Site — Pleven
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Plovdiv
• Clinical Site — Rousse
• … and 3 more centers

Germany · 10 centers

• Clinical Site — Berlin
• Clinical Site — Berlin
• … and 8 more centers

Hungary · 9 centers

Center list to be confirmed — check the primary protocol.

Georgia · 8 centers

• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi
• Clinical Site — Tbilisi

France · 6 centers

• Clinical Site — Caluire-et-Cuire
• Clinical Site — Montpellier
• Clinical Site — Narbonne
• Clinical Site — Nice
• Clinical Site — Rouen
• Clinical Site — Tours

Canada · 5 centers

• Clinical Site — Toronto
• Clinical Site — Calgary
• Clinical Site — Trois-Rivières
• Clinical Site — Waterloo
• Clinical Site — Winnipeg

Czechia · 4 centers

• Clinical Site — Brno
• Clinical Site — Ostrava
• Clinical Site — Studénka
• Clinical Site — Zlín

United Kingdom · 3 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06641089 · M1095-PSA-302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗