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Clinical Trials/EUCTR2021-000665-32-IT
EUCTR2021-000665-32-IT
Active, not recruiting
Phase 1

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) - NA

JANSSEN CILAG INTERNATIONAL NV0 sites150 target enrollmentSeptember 8, 2021
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ConditionsPrimary Sjogren's SyndromeMedDRA version: 21.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Primary Sjogren's Syndrome
Sponsor
JANSSEN CILAG INTERNATIONAL NV
Enrollment
150
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 8, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Meets classification criteria for primary sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) within 5 years but at least 6 months prior to screening
  • •\- At screening is seropositive for antibodies to pSS\-associated antigen A (60 kilodalton \[kDa] Ro/sjogren's syndrome\-related antigen \[SSA])
  • •\- Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) score greater than or equal to (\>\=) 6 and less than or equal to (\<\=) 13
  • •\- At least low activity as defined in the biological domain of European League Against Rheumatism (EULAR) and in at least low activity in at least one of the following ESSDAI domains: cutaneous, articular, glandular, constitutional, hematologic, and lymphadenopathy
  • •\- It is recommended that participants are up to date on all age\-appropriate vaccinations prior to screening as per routine local medical guidelines. For study participants who received locally\-approved (and including emergency use\-authorized) coronavirus disease 2019 (COVID\-19\) vaccines recently prior to study entry, applicable local vaccine labelling, guidelines, and standards\-of\-care for participants receiving immune\-targeted therapy will be followed when determining an appropriate interval between vaccination and study enrollment.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 135
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\-Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her pSS or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
  • •\- Comorbidities (for example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
  • •\- Has any unstable or progressive manifestation of pSS that is likely to warrant escalation in therapy beyond permitted background medications and/or has severely active pSS (clinESSDAI score greater than \[\>] 13\)
  • •\- Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention
  • •\- Has sjogren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition (for example, rheumatoid arthritis \[RA], systemic lupus erythematosus \[SLE], scleroderma, inflammatory bowel disease \[IBD]) is the primary diagnosis or has clinical manifestations that, in the opinion of the
  • •investigator, are likely to interfere with the investigator's ability to assess pSS manifestations

Outcomes

Primary Outcomes

Not specified

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