A Study of Guselkumab in Participants With Systemic Sclerosis

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT04683029
Phase
PHASE2
Status
Completed

Conditions

  • Scleroderma, Systemic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab Dose 1 — DRUG
    Guselkumab Dose 1 will be administered intravenously.
  • Guselkumab Dose 2 — DRUG
    Guselkumab Dose 2 will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered intravenously or subcutaneously.

Study Details

The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).

Key Dates

Start date
Feb 24, 2021
Status verified
Jul 2025
Primary completion
May 17, 2023
Completion
Jul 9, 2024

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Guselkumab
    Participants will receive intravenous (IV) injection of Guselkumab Dose 1 at Week 0, 4, and 8 followed by subcutaneous (SC) injection of Dose 2 Guselkumab every 4 weeks (Q4W) from Week 12 to Week 48 (end of maintenance phase). Participants will receive SC injection of Guselkumab Dose 2 and IV injection of placebo at long-term extension (LTE) Weeks 52, 56, and 60 followed by SC injection of Guselkumab Dose 2 Q4W from LTE Week 64 until Week 100.
  • Placebo Comparator: Group B: Placebo
    Participants will receive IV injection of matching placebo at Week 0, 4, and 8 followed by SC injection of matching placebo Q4W from Week 12 to Week 48 (end of maintenance phase). Participants will receive SC injection of Placebo and IV injection of Guselkumab Dose 1 at LTE Weeks 52, 56, and 60 followed by SC injection of Guselkumab Dose 2 Q4W from LTE Week 64 until Week 100.

Primary Outcome Measure

Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 [ Time Frame: Baseline and Week 24 ]

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