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

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Lupus Arthritis

Treatments: Drug: Laquinimod; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01085084

LA-LAQ-202

Details and patient eligibility

About

The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams [mg] and 1 mg) in participants with active lupus arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosed with SLE.
• Participants with active lupus arthritis as evident by at least 4 tender and 4 swollen joints at screening and baseline visits, and moderate or severe arthritis with active synovitis in at least 1 joint, with some loss of functional range of movement present at screening and baseline visits.

Exclusion criteria

• The participant's estimated glomerular filtration rate (eGFR) was less than or equal to 30 milliliters (mL)/minute/1.73 square meter (m^2), as calculated by the Modification of Diet in Renal Disease (MDRD) formula at the screening visit.
• Participants with severe, unstable and/or progressive central nervous system (CNS) lupus and/or associated with significant cognitive impairment (upon the investigators' judgement).
• Participants with a clinically significant or unstable medical or surgical condition that, in the investigator's opinion, would preclude safe and complete study participation.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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82 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.

Treatment:

Drug: Placebo

Laquinimod 0.5 mg

Experimental group

Description:

Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.

Treatment:

Drug: Laquinimod

Drug: Placebo

Laquinimod 1 mg

Experimental group

Description:

Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.

Treatment:

Drug: Laquinimod