Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

NCT05432531 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-04

No results posted yet for this study

Summary

Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.

Conditions

Interventions

DRUG

Anti JAK1,2

Induction of remission of active lupus nephritis

DRUG

Cyclophosphamid

Induction of remission of active lupus nephritis

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Manal M Hassanien, Md · Associate professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-12-31
Completion
2023-04-01

Countries

  • Egypt

Study Locations

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Entities

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 NCT05432531 on ClinicalTrials.gov