A Study of Guselkumab in Participants With Systemic Sclerosis

NCT ID: NCT04683029

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-24
• Study Completion Date: 2024-07-09

Brief Summary

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

Conditions

Scleroderma, Systemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Guselkumab Dose 1

Intervention Type: DRUG

Guselkumab Dose 1 will be administered intravenously.

Guselkumab Dose 2

Intervention Type: DRUG

Guselkumab Dose 2 will be administered subcutaneously.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered intravenously or subcutaneously.

Interventions

Guselkumab Dose 1

Guselkumab Dose 1 will be administered intravenously.

Intervention Type: DRUG

Guselkumab Dose 2

Guselkumab Dose 2 will be administered subcutaneously.

Intervention Type: DRUG

Placebo

Placebo will be administered intravenously or subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of systemic sclerosis (SSc) according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria
• Diffuse cutaneous SSc according to the LeRoy criteria that is, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
• Disease duration of ≤36 months (defined as time from first non-Raynaud phenomenon manifestation).
• Greater than or equal to (>=) 10 and less than or equal to (<=) 22 modified Rodnan skin score (mRSS) units at screening and Week 0
• Forced vital capacity (FVC) >= 60 percent (%) of predicted at screening
• Diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted (hemoglobin-corrected) at screening.
• Participants who meet 1 of the following criteria at screening: increase of >=3 mRSS units, compared with an assessment performed within the previous 2 to 6 months; Involvement of 1 new body area with an increase of >=2 mRSS units compared with an assessment performed within the previous 2 to 6 months; and Involvement of 2 new body areas with increase of >=1 mRSS units compared with the assessment within the previous 2 to 6 months

Exclusion Criteria

• History of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Has any known severe or uncontrolled SSc complications including hemoptysis, pulmonary hemorrhage, renal crisis
• Has an interstitial lung disease requiring oxygen therapy
• Has any rheumatic disease other than SSc such as rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), systemic lupus erythematosus, polymyositis/dermatomyositis that could interfere with assessment of SSc
• Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Chukyo Hospital

Aichi, , Japan

The University of Tokyo Hospital

Tokyo, , Japan

Wakayama Medical University Hospital

Wakayama, , Japan

University of Fukui Hospital

Yoshida, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNTO1959SSC2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108936

Identifier Type: -

Identifier Source: org_study_id