A Study of Guselkumab in Participants With Systemic Sclerosis

NCT04683029 | Completed Phase 2 Results

• 2 other identifiers: CR108936CNTO1959SSC2001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Scleroderma, Systemic

Outcome Measures

Primary Outcomes (1)

• Main Study: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24

  Change from baseline in mRSS at Week 24 was reported. The mRSS is an accepted clinical measure of skin thickness. The investigator assessed the thickening of the skin using the mRSS through simple palpation on 17 different skin sites in the fingers, hands, forearms, arms, feet, legs, and thighs (bilaterally) and face, chest, and abdomen (singly). Each skin site was rated on a 0 to 3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness and unable to pinch. Individual skin scores in the 17 body areas were summed and defined as the total mRSS which ranged from 0 (no thickening) to 51 (severe thickening), where higher score indicated more severity of skin thickening/worst outcome.

  Baseline and Week 24

Secondary Outcomes (19)

• Main Study: Change From Baseline in Modified Rodnan Skin Score at Week 52

  Baseline and Week 52

• Main Study: Percentage of Participants Who Experienced Worsening of Modified Rodnan Skin Score at Week 24 and Week 52

  Week 24 and Week 52

• Main Study: Percentage of Participants Who Achieved a Score of 0.6 in American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) at Week 24 and Week 52

  Week 24 and Week 52

• Main Study: Change From Baseline in Forced Vital Capacity (FVC) at Week 24 and Week 52

  Baseline, Week 24 and Week 52

• Main Study: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 24 and Week 52

  Baseline, Week 24 and Week 52

Study Arms (2)

Group A: Guselkumab

EXPERIMENTAL

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.

Drug: Guselkumab Dose 1; Drug: Guselkumab Dose 2

Group B: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Guselkumab Dose 1 DRUG

Guselkumab Dose 1 will be administered intravenously.

Group A: Guselkumab

Guselkumab Dose 2 DRUG

Guselkumab Dose 2 will be administered subcutaneously.

Group A: Guselkumab

Placebo DRUG

Placebo will be administered intravenously or subcutaneously.

Group B: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (4)

Chukyo Hospital

Aichi, 457 8510, Japan

Location

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

Wakayama Medical University Hospital

Wakayama, 641 8510, Japan

Location

University of Fukui Hospital

Yoshida, 910-1193, Japan

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Senior Director Clinical Research MD
• Organization: Janssen Pharmaceutical K.K.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 24, 2020
• Study Start: February 24, 2021
• Primary Completion: May 17, 2023
• Study Completion: July 9, 2024
• Last Updated: July 23, 2025
• Results First Posted: October 9, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (4)