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NCT04683029CompletedPhase 2

A Study of Guselkumab in Participants With Systemic Sclerosis

A Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Guselkumab in Participants With Systemic Sclerosis

Source: ClinicalTrials.gov · Last updated 23 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
56 (actual)
First submitted
22 Dec 2020
Start date
24 Feb 2021
Primary completion date
17 May 2023
Lead sponsor
Janssen Pharmaceutical K.K.
NCT number
NCT04683029

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 56
  • From 24 Feb 2021 to the primary completion date, 17 May 2023
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)

Other illness

  • 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

Lab values

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chukyo Hospital
Coordinator of this site? Confirm its status
AichiJapanUnknown status
The University of Tokyo Hospital
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Wakayama Medical University Hospital
Coordinator of this site? Confirm its status
WakayamaJapanUnknown status
University of Fukui Hospital
Coordinator of this site? Confirm its status
YoshidaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.