Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

NCT ID: NCT05432531

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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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.

The baricitinib 4 mg dose suggestive to significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the idea for future trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for

Conditions

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Lupus Nephritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
patient and outcome assessor

Study Groups

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Baracetinib

oral tablet 4 mg baricitinib and placebo IV infusion/ month

Group Type EXPERIMENTAL

Anti JAK1,2

Intervention Type DRUG

Induction of remission of active lupus nephritis

Cyclophosphamide

IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily

Group Type ACTIVE_COMPARATOR

Cyclophosphamid

Intervention Type DRUG

Induction of remission of active lupus nephritis

Interventions

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Anti JAK1,2

Induction of remission of active lupus nephritis

Intervention Type DRUG

Cyclophosphamid

Induction of remission of active lupus nephritis

Intervention Type DRUG

Other Intervention Names

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Baritava Indoxan

Eligibility Criteria

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Inclusion Criteria

* lupus nephritis

Exclusion Criteria

* cardiac disease Thrombosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Manal Hassanien

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal M Hassanien, Md

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

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Manal Hassanien

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Baracetinib

Identifier Type: -

Identifier Source: org_study_id

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