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Enrolling by invitation NCT07223138

A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Psoriatic Arthritis

Phase III Interventional Arthritis, Psoriatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonelokimab.
Who it may be relevant to
Registry conditions: Arthritis, Psoriatic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a study to demonstrate the long-term safety, tolerability and clinical efficacy of sonelokimab in the treatment of patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302)

Detailed description

M1095-PSA-303 is a Phase 3, multicenter, open-label extension study to investigate the long-term safety, tolerability and clinical efficacy of sonelokimab 60 mg subcutaneously every 4 weeks in patients with psoriatic arthritis who completed a parental study (M1095-PSA-301 or M1095-PSA-302).

Interventions

  • Drug Sonelokimab
    Open-label

Primary outcome measures

  • Long-term safety and tolerability of sonelokimab: [Time frame: 52 weeks]
  • Long-term safety and tolerability of sonelokimab: [Time frame: 52 weeks]
  • Long-term safety and tolerability of sonelokimab: [Time frame: 52 weeks]
  • Long-term safety and tolerability of sonelokimab: [Time frame: 52 weeks]
  • Long-term safety and tolerability of sonelokimab: [Time frame: 52 weeks]
  • Long-term safety and tolerability of sonelokimab: [Time frame: 52 weeks]
Secondary outcome measures (10)
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long-term efficacy of sonelokimab: [Time frame: 52 weeks]
  • Long term efficacy of sonelokimab [Time frame: 52 weeks]

Eligibility criteria

Inclusion criteria

  • Participants who, in the opinion of the investigator, are expected to benefit from participation in this OLE study.
  • Participants who have received the second to last and/or last dose, as planned in the parental study, and have completed the end-of-treatment visit of the parental study.
  • Participants must have received their last dose of study treatment in the parental study no more than 8 weeks (but ideally 4 weeks) before the first dose in this OLE study.
  • Female participants are eligible to participate if they are not pregnant or breastfeeding and must be of nonchildbearing potential or must agree to use highly effective methods of contraception during the study and for at least 8 weeks after the last dose of study treatment. Female participant of childbearing potential must refrain from donating oocytes during the study and for at least 8 weeks after the last dose of study treatment.
  • Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for at least 8 weeks after the last dose of study treatment, unless surgically sterile. Male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment.

Exclusion criteria

  • Participants who met any of the discontinuation criteria of the parental study at the time of enrollment in this OLE study.
  • Participants who have ongoing or planned use of one or more of the prohibited PsA or non-PsA treatments specified in this protocol.
  • Participants who plan to participate in another interventional study for a drug or device during this study.
  • Participants who were unblinded during the parental study.
  • Participant noncompliance to the parental study

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 16 centers
  • Clinical Site — Avondale
  • Clinical Site — Mesa
  • Clinical Site — Phoenix
  • Clinical Site — Tucson
  • Clinical Site — Jonesboro
  • Clinical Site — Upland
  • Clinical Site — Avon Park
  • Clinical Site — Clearwater
  • … and 8 more centers

Identifiers

NCT: NCT07223138 · M1095-PSA-303 · IZAR-OLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗