Lupus or SLEPhase 2/3NCT05686746
Use of Baricitenib to Maintain of Remission
A Phase 2/3 study testing Baricitinib 4 MG, Baricitinib 2 MG and MMF in people with Lupus or SLE and Nephritis, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Lupus or SLE, Nephritis
- What is being tested?
- Baricitinib 4 MG, Baricitinib 2 MG and MMF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Aug 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Lupus nephritis Disease
- Must be able to swallow tablets
- lupus nephritis in remission
Who cannot join
- antiphospholipid syndrome disease
- thrombosis history
- sever anemia, leukopenia or thrombocytopenia
- impaired liver and renal function
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Manal Hassanien
Asyut, Yes, 7111
Manal M Hassanien, MD, +201062679200, manal_hassanien@yahoo.com
Manal Hassanien, +201062679200, manal_hassanien@yahoo.com
About this study
Official title: Uses of Baricetinib 4 mg or 2mg Versus MMF to Maintain Lupus Remission Randomized Controlled Trial: Outcomes Over 2 Years
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.
Read the detailed description
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. Objectives: To assess the efficacy and safety of Baricitinib in patients (pts) with LN by dose 4mg versus 2 mg versus MMF 1 gm daily dose.
- Conditions
- Lupus or SLE, Nephritis
- Being tested
- Baricitinib 4 MG, Baricitinib 2 MG, MMF
- Medical subject headings
- Lupus Erythematosus, Systemic, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 MGDrug
4 mg oral daily
Baricitinib 2 MGDrug
2 mg oral daily
MMFDrug
1000 mg oral daily
| Study group | Role | What they receive |
|---|---|---|
| Baricetinib 4 mg | Experimental | 4 mg oral tablet daily Receives: Drug: Baricitinib 4 MG |
| Baricetinib 2 mg | Experimental | 2 mg oral tablet daily Receives: Drug: Baricitinib 2 MG |
| MMF | Active comparator | MMF 500 mg tablet twice daily Receives: Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
proteins creatinine ratio
nephritis
Measured: 3 months
proteins creatinine ratio
nephritis
Measured: 6 months
proteins creatinine ratio
nephritis
Measured: 1 year
Secondary outcomes (9)
complement 3
serum level
Measured: 3 months
complement 3
serum level
Measured: 6 months
complement 3
serum level
Measured: 1 year
anti ds DNA
serum level
Measured: 3 months
anti ds DNA
serum level
Measured: 6 months
anti ds DNA
serum level
Measured: 1 year
ANA
serum level
Measured: 3 months
ANA
serum level
Measured: 6 months
ANA
serum level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus or SLEStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
- Investigators
- Manal Hassanien, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686746
- Sponsor's protocol ID
- systemic lupus
- Status last verified
- Jan 2023
- First submitted
- 25 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after finishing study
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uses of Baricetinib 4 mg or 2mg Versus MMF to Maintain Lupus Remission Randomized Controlled Trial: Outcomes Over 2 Years
- ClinicalTrials.gov ID
- NCT05686746
- Acronym / sponsor ID
- systemic lupus
- Conditions
- Lupus or SLE, Nephritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Objectives: To assess the efficacy and safety of Baricitinib in patients (pts) with LN by dose 4mg versus 2 mg versus MMF 1 gm daily dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baricetinib 4 mg | Experimental | Drug: Baricitinib 4 MG4 mg oral tablet daily |
| Baricetinib 2 mg | Experimental | Drug: Baricitinib 2 MG2 mg oral tablet daily |
| MMF | Active comparator | Drug: MMFMMF 500 mg tablet twice daily |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Lupus nephritis Disease
- Must be able to swallow tablets
- lupus nephritis in remission
Key exclusion criteria (4 listed)
- antiphospholipid syndrome disease
- thrombosis history
- sever anemia, leukopenia or thrombocytopenia
- impaired liver and renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib 4 MG4 mg oral daily | Drug | Baricetinib 4 mg |
| Baricitinib 2 MG2 mg oral daily | Drug | Baricetinib 2 mg |
| MMF1000 mg oral daily | Drug | MMF |
Primary outcome
proteins creatinine ratio
Time frame: 3 months
nephritis
proteins creatinine ratio
Time frame: 6 months
nephritis
proteins creatinine ratio
Time frame: 1 year
nephritis
9 secondary outcomes
complement 3
Time frame: 3 months
complement 3
Time frame: 6 months
complement 3
Time frame: 1 year
anti ds DNA
Time frame: 3 months
anti ds DNA
Time frame: 6 months
anti ds DNA
Time frame: 1 year
ANA
Time frame: 3 months
ANA
Time frame: 6 months
ANA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No. after finishing study
Related trials for Lupus or SLE
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal Hassanien, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baricitinib 4 MG, Baricitinib 2 MG and MMF in people with Lupus or SLE and Nephritis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Hassanien, MD (00201062679200, manal_hassanien@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proteins creatinine ratio (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.