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Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome

NCT05383677 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-19

No results posted yet for this study

Summary

The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of ≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response at week 24.

Conditions

  • Sjogren's Syndrome

Interventions

DRUG

Anifrolumab

Anifrolumab 300 mg will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks.

DRUG

Placebo

Placebo will be administered in intravenous infusions once per 4 weeks, for a total treatment period of 24 weeks.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Hendrika Bootsma · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-05-01
Completion
2024-08-01
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05383677 on ClinicalTrials.gov