Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

December 30, 2022 updated by: Manal Hassanien, Assiut University

Efficiency of Baracetinib to Induce Remission of Active Lupus Nephritis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71111
        • Manal Hassanien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lupus nephritis

Exclusion Criteria:

  • cardiac disease Thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Baracetinib
oral tablet 4 mg baricitinib and placebo IV infusion/ month
Drug: Anti JAK1,2
Induction of remission of active lupus nephritis
Other Names:
  • Baritava
Active Comparator: Cyclophosphamide
IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily
Drug: Cyclophosphamid
Induction of remission of active lupus nephritis
Other Names:
  • Indoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Album in urine
Time Frame: 6 months
24 h protein in urine
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complement 3
Time Frame: 3 and 6 months
serum level
3 and 6 months
anti double strand DNA
Time Frame: 3 and 6 months
serum level
3 and 6 months
lupus activity index-2K
Time Frame: 3 and 6 months
SLEDAI-2k
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Manal M Hassanien, Md, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Baracetinib

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

After completing the study and published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe