Lupus NephritisPhase 2NCT01085097

A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis

A Phase 2 study testing Laquinimod, Mycophenolate Mofetil and Prednisolone/Prednisone in people with Lupus Nephritis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 30 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil [MMF] and… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lupus Nephritis
What is being tested?: Laquinimod, Mycophenolate Mofetil and Prednisolone/Prednisone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 30 sitesin 5 countries
Study dates: 1 Sep 2010to 24 Oct 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants diagnosed with SLE
Kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous Lupus Nephritis (LN)
Clinically active Lupus Nephritis as evident by urine protein-to-creatinine ratio (UPCR) of 1 or higher, for LN classes III, IV, or class V in combination with classes III or IV, or a UPCR of 2 or higher for LN class V, at screening or any time between screening and baseline.

Who cannot join

Participants with severe renal impairment or dialysis
Participants with a clinically significant or unstable medical or surgical condition
Women who are pregnant or nursing or who intend to be during the study period
Women of child-bearing potential who do not practice an acceptable method of birth control NOTE: Other inclusion and exclusion criteria may apply.

Trial locations and contacts

30 sites in 5 countries.

Country

City, postcode or hospital

30 sites in 5 countries

United States14 sites

Teva Investigational Site 1031
Baltimore, Maryland, 21205
Teva Investigational Site 1030
Charleston, South Carolina, 29425
Teva Investigational Site 1020
Charlotte, North Carolina, 28210
Teva Investigational Site 1026
Chattanooga, Tennessee, 37408
Teva Investigational Site 1016
Columbus, Ohio, 43210
Teva Investigational Site 1024
La Jolla, California, 92037-0943
Teva Investigational Site 1022
Lake Success, New York, 11042
Teva Investigational Site 1028
Los Angeles, California, 90048
Teva Investigational Site 1018
Manhasset, New York, 11030
Teva Investigational Site 1019
New York, New York, 10016
Teva Investigational Site 1017
New York, New York, 10032
Teva Investigational Site 1032
Phoenix, Arizona, 85012
Teva Investigational Site 1021
Rochester, Minnesota, 55905
Teva Investigational Site 1025
San Leandro, California, 94578

Other trials in United States

Russia6 sites

Teva Investigational Site 5006
Kazan', 420064
Teva Investigational Site 5007
Kemerovo, 650029
Teva Investigational Site 5001
Moscow, 115522
Teva Investigational Site 5003
Moscow, 123182
Teva Investigational Site 5002
Moscow, 125284
Teva Investigational Site 5005
Yaroslavl, 150062

Other trials in Russia

United Kingdom5 sites

Teva Investigational Site 3413
Birmingham, B15 2TH
Teva Investigational Site 3409
Cambridge, CB2 0QQ
Teva Investigational Site 3412
Dudley, DY1 2HQ
Teva Investigational Site 3410
London, SE1 7EH
Teva Investigational Site 3411
Manchester, M13 9WL

Other trials in United Kingdom

Canada3 sites

Teva Investigational Site 1115
Edmonton, Alberta, T6G 2B7
Teva Investigational Site 1113
Toronto, Ontario, M5T 2S8
Teva Investigational Site 1114
Winnipeg, Manitoba, R3A 1M4

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France2 sites

Teva Investigational Site 3510
Lille, 59057
Teva Investigational Site 3509
Paris, 75013

Other trials in France

About this study

Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)

Conditions: Lupus Nephritis
Being tested: Laquinimod, Mycophenolate Mofetil, Prednisolone/Prednisone, Placebo, Methylprednisolone
Keywords: Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Laquinimod
Medical subject headings: Lupus Nephritis, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LaquinimodDrug
Laquinimod will be administered per dose and schedule specified in the arm description.
Mycophenolate MofetilDrug
Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.
Prednisolone/PrednisoneDrug
Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.
PlaceboDrug
Placebo matching to laquinimod will be administered per schedule specified in the arm description.
MethylprednisoloneDrug
Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.

Study groups in NCT01085097
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive 2 capsules of placebo matching to laquinimod orally once daily (QD) for 24 weeks, MMF 500 mg tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and MP 500 mg/day intravenously (IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Receives: Drug: Mycophenolate Mofetil; Drug: Prednisolone/Prednisone; Drug: Placebo; Drug: Methylprednisolone
Laquinimod 0.5 mg	Experimental	Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matching to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Receives: Drug: Laquinimod; Drug: Mycophenolate Mofetil; Drug: Prednisolone/Prednisone; Drug: Placebo; Drug: Methylprednisolone
Laquinimod 1 mg	Experimental	Participants will receive 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28. Receives: Drug: Laquinimod; Drug: Mycophenolate Mofetil; Drug: Prednisolone/Prednisone; Drug: Methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Measured: Baseline up to Week 28
Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201024 Oct 2012

First posted11 Mar 2010 (estimated)
Study start1 Sep 2010
Primary completion24 Oct 2012
Study completion24 Oct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lupus NephritisStudies of the same condition, open and under way.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01085097
Sponsor's protocol ID: LN-LAQ-201
Other IDs: 2010-018329-20
Status last verified: Feb 2022
First submitted: 4 Mar 2010
Last updated: 9 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dapagliflozin in Active Lupus Nephritis
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Not yet recruiting
MYTP01 for Immune-Mediated Diseases
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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
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All Lupus Nephritis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)
ClinicalTrials.gov ID: NCT01085097
Acronym / sponsor ID: LN-LAQ-201
Conditions: Lupus Nephritis
Keywords: Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Laquinimod
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2010 (actual)
Primary completion: 24 Oct 2012 (actual)
Study completion: 24 Oct 2012 (actual)
First posted: 11 Mar 2010 (estimated)
Results: Posted 9 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Mycophenolate Mofetil, Drug: Prednisolone/Prednisone, Drug: Placebo, Drug: MethylprednisoloneParticipants will receive 2 capsules of placebo matching to laquinimod orally once daily (QD) for 24 weeks, MMF 500 mg tablet orally twice daily (BID) for the first week then 1 gram (g) BID from Week 2 to Week 28, and MP 500 mg/day intravenously (IV) from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Laquinimod 0.5 mg	Experimental	Drug: Laquinimod, Drug: Mycophenolate Mofetil, Drug: Prednisolone/Prednisone, Drug: Placebo, Drug: MethylprednisoloneParticipants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matching to laquinimod orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.
Laquinimod 1 mg	Experimental	Drug: Laquinimod, Drug: Mycophenolate Mofetil, Drug: Prednisolone/Prednisone, Drug: MethylprednisoloneParticipants will receive 2 capsules of laquinimod 0.5 mg orally QD for 24 weeks, MMF 500 mg tablet orally BID for the first week then 1 g BID from Week 2 to Week 28, and MP 500 mg/day IV from Days 1 through 3, followed by oral prednisolone/prednisone (initial dose 40 mg/day which is tapered to 10 mg/day or less by the end of Week 20, on a fixed steroid-tapering regimen) from Day 4 through Week 28.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Participants diagnosed with SLE
Kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous Lupus Nephritis (LN)
Clinically active Lupus Nephritis as evident by urine protein-to-creatinine ratio (UPCR) of 1 or higher, for LN classes III, IV, or class V in combination with classes III or IV, or a UPCR of 2 or higher for LN class V, at screening or any time between screening and baseline.

Key exclusion criteria (4 listed)

Participants with severe renal impairment or dialysis
Participants with a clinically significant or unstable medical or surgical condition
Women who are pregnant or nursing or who intend to be during the study period
Women of child-bearing potential who do not practice an acceptable method of birth control NOTE: Other inclusion and exclusion criteria may apply.

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
LaquinimodLaquinimod will be administered per dose and schedule specified in the arm description.	Drug	Laquinimod 0.5 mg, Laquinimod 1 mg
Mycophenolate MofetilMycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.	Drug	Laquinimod 0.5 mg, Laquinimod 1 mg, Placebo
Prednisolone/PrednisonePrednisolone/Prednisone will be administered per dose and schedule specified in the arm description.	Drug	Laquinimod 0.5 mg, Laquinimod 1 mg, Placebo
PlaceboPlacebo matching to laquinimod will be administered per schedule specified in the arm description.	Drug	Laquinimod 0.5 mg, Placebo
MethylprednisoloneMethylprednisolone (MP) will be administered per dose and schedule specified in the arm description.	Drug	Laquinimod 0.5 mg, Laquinimod 1 mg, Placebo

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Week 28
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
Time frame: Baseline, Week 24
Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease (MDRD) formula.

Results and safety

Results posted to the registry on 9 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	15	13
Laquinimod 0.5 mg	16	16
Laquinimod 1 mg	15	13

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Baseline up to Week 28. Number. Unit: participants

Measure	Placebo n = 15	Laquinimod 0.5 mg n = 16	Laquinimod 1 mg n = 15
Value	14	15	15

Population analysed: Safety analysis set included all randomly assigned participants who received at least 1 dose of study drug. In this set, participants were assigned to the treatment actually received, regardless of the assigned treatment.

Primary outcome: Percent Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24

Time frame: Baseline, Week 24. Mean (Standard Deviation). Unit: percent change

Measure	Placebo n = 15	Laquinimod 0.5 mg n = 16	Laquinimod 1 mg n = 15
Value	12.1 (20.17)	18.0 (30.65)	24.3 (28.84)

Population analysed: Modified intent-to-treat (mITT) analysis set included all randomized participants, excluding observations after treatment failure.

Adverse events

Time frame: Baseline up to Week 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 15 (26.7%)	14 of 15 (93.3%)	0 of 15
Laquinimod 0.5 mg	4 of 16 (25%)	13 of 16 (81.3%)	0 of 16
Laquinimod 1 mg	4 of 15 (26.7%)	15 of 15 (100%)	1 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Teva Medical Expert, M.D. study director

Teva Branded Pharmaceutical Products R&D, Inc.

30 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laquinimod, Mycophenolate Mofetil and Prednisolone/Prednisone in people with Lupus Nephritis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 30 sites in 5 countries.

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: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Russia, United Kingdom, Canada, France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) (time frame: Baseline up to Week 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01085097.

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 9 Mar 2022.