NCT05686746

Brief Summary

Baricitinib a selective Janus kinase (JAK) inhibitors 1\&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

December 25, 2022

Last Update Submit

January 13, 2023

Conditions

Lupus or SLENephritis

Outcome Measures

Primary Outcomes (3)

  • proteins creatinine ratio

    nephritis

    3 months

  • proteins creatinine ratio

    nephritis

    6 months

  • proteins creatinine ratio

    nephritis

    1 year

Secondary Outcomes (9)

  • complement 3

    3 months

  • complement 3

    6 months

  • complement 3

    1 year

  • anti ds DNA

    3 months

  • anti ds DNA

    6 months

  • +4 more secondary outcomes

Study Arms (3)

Baricetinib 4 mg

EXPERIMENTAL

4 mg oral tablet daily

Drug: Baricitinib 4 MG

Baricetinib 2 mg

EXPERIMENTAL

2 mg oral tablet daily

Drug: Baricitinib 2 MG

MMF

ACTIVE COMPARATOR

MMF 500 mg tablet twice daily

Drug: MMF

Interventions

Baricitinib 4 MGDRUG

4 mg oral daily

Baricetinib 4 mg
Baricitinib 2 MGDRUG

2 mg oral daily

Baricetinib 2 mg
MMFDRUG

1000 mg oral daily

MMF

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Lupus nephritis Disease
  • Must be able to swallow tablets
  • lupus nephritis in remission

You may not qualify if:

  • antiphospholipid syndrome disease
  • thrombosis history
  • sever anemia, leukopenia or thrombocytopenia
  • impaired liver and renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal Hassanien

Asyut, Yes, 7111, Egypt

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicNephritis

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Manal Hassanien, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal Hassanien, MD

CONTACT

00201062679200manal_hassanien@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
participant and investigator and outcome assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 25, 2022

First Posted

January 17, 2023

Study Start

June 1, 2022

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

after finishing study

Locations

EG(1)