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Clinical Trials List

Protocol Number80202135SJS3001
Active

2024-11-12 - 2030-12-19

Phase III

Recruiting7

ICD-10M35.00

Sicca syndrome, unspecified

ICD-10M35.01

Sicca syndrome with keratoconjunctivitis

ICD-10M35.09

Sicca syndrome with other organ involvement

ICD-9710.2

Sicca syndrome

A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 3 Protocol to Assess the Efficacy and Safety of Nipocalimab in Adults with Moderate to Severe Sjogren’s Disease (SjD)

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Wei-Sheng Chen 風濕免疫科
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 許鐘元 Division of Rheumatology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yao-Fan Fang Division of Rheumatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 李岱儒 風濕免疫科
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王立峰 Division of Rheumatology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Joung-Liang Lan 風濕免疫科
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Sheng Chang
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Moderate to Severe Sjogren’s Disease (SjD)

Objectives

To evaluate the efficacy of nipocalimab compared to placebo in participants with moderate to severe SjD

Test Drug

injective

Active Ingredient

Nipocalimab

Dosage Form

220

Dosage

MG/ML

Endpoints

Change from baseline in ClinESSDAI score at Week 48

Inclution Criteria

Each potential participant must satisfy all of the following criteria to be enrolled in the study:
Age
1. Criterion modified per Amendment 3
1.1. ≥18 years of age or local legal age for consent.

Exclusion Criteria

1. Has a history of severe, progressive and/or uncontrolled hepatic (eg,
viral/alcoholic/autoimmune hepatitis and/or metabolic liver disease), gastrointestinal,
renal, pulmonary, cardiovascular, psychiatric, neurological ormusculoskeletal disorder,
hypertension, and/or any other medical or uncontrolled autoimmune disorder(s) (eg,
diabetes mellitus) or clinically significant abnormalities in screening laboratory that
might interfere with the patient’s full participation in the study, or might jeopardize the
safety of the participant or the validly of the study results.
Note: Any condition for which, in the opinion of the investigator, participation would
not be in the best interest of the participants (eg, compromise well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
2. Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer
to the IB), or excipients used in the placebo formulation (refer to Section 6).
3. Has any confirmed or suspected clinical immunodeficiency syndrome not related to
treatment of his/her SjD or has a family history of congenital or hereditary
immunodeficiency unless confirmed absent in the participant.

The Estimated Number of Participants

  • Taiwan

    49 participants

  • Global

    600 participants

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