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Status:

COMPLETED

A Study of Guselkumab in Participants With Systemic Sclerosis

Lead Sponsor:

Janssen Pharmaceutical K.K.

Conditions:

Scleroderma, Systemic

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    February 24 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 9 2024

    Estimated Enrollment :

    56 Patients enrolled

    Trial Details

    Trial ID

    NCT04683029

    Start Date

    February 24 2021

    End Date

    July 9 2024

    Last Update

    July 23 2025

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Chukyo Hospital

    Aichi, Japan, 457 8510

    2

    The University of Tokyo Hospital

    Tokyo, Japan, 113-8655

    3

    Wakayama Medical University Hospital

    Wakayama, Japan, 641 8510

    4

    University of Fukui Hospital

    Yoshida, Japan, 910-1193