A Study of Guselkumab in Participants With Systemic Sclerosis

  • STATUS
    Recruiting
  • End date
    Nov 22, 2022
  • participants needed
    56
  • sponsor
    Janssen Pharmaceutical K.K.
Updated on 10 October 2021
carbon monoxide
fibrosis
rheumatism
raynaud's phenomenon
raynaud's syndrome
MRSS

Summary

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

Details
Condition Scleroderma, Systemic sclerosis
Treatment Placebo, Guselkumab Dose 1, Guselkumab Dose 2
Clinical Study IdentifierNCT04683029
SponsorJanssen Pharmaceutical K.K.
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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