Trial Outcomes & Findings for A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Arthritis (NCT NCT01085084)

Last Updated: 2022-07-07

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Baseline up to Week 16

Results posted on

2022-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 0.5 mg Participants received 1 capsule of laquinimod 0.5 milligrams (mg) and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 1 mg Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Overall Study STARTED	26	28	28
Overall Study Received at Least 1 Dose of Study Drug	26	28	28
Overall Study Safety Analysis Set	25	29	28
Overall Study COMPLETED	19	23	19
Overall Study NOT COMPLETED	7	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 0.5 mg Participants received 1 capsule of laquinimod 0.5 milligrams (mg) and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 1 mg Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Overall Study Withdrawal by Subject	1	0	0
Overall Study Lost to Follow-up	2	1	1
Overall Study Adverse Event	4	3	6
Overall Study Treatment Failure	0	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 0.5 mg n=28 Participants Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 1 mg n=28 Participants Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.	Total n=82 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 13.5 • n=5 Participants	46.6 years STANDARD_DEVIATION 12.0 • n=7 Participants	46.8 years STANDARD_DEVIATION 13.4 • n=5 Participants	47.1 years STANDARD_DEVIATION 12.8 • n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	25 Participants n=7 Participants	26 Participants n=5 Participants	75 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	22 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 0.5 mg n=29 Participants Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 1 mg n=28 Participants Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Number of Participants With Adverse Events (AEs)	21 Participants	29 Participants	25 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to a treatment, regardless of which treatment they actually received, excluding observations after treatment failure. Here 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

The number of swollen joints was used to assess lupus arthritis activity. Joint swelling was defined as soft tissue swelling that was detectable along the joint margins. 66 joints were examined for swelling. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 0.5 mg n=27 Participants Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 1 mg n=26 Participants Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Percent Change From Baseline in Swollen Joint Count at Week 12	-36.9 percent change Standard Deviation 78.1	-36.7 percent change Standard Deviation 47.0	-40.5 percent change Standard Deviation 55.6

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The mITT analysis set included all participants who were randomly assigned to a treatment, regardless of which treatment they actually received, excluding observations after treatment failure. Here 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

The number of tender joints was used to assess lupus arthritis activity. Joint tenderness was defined as the presence or absence of tenderness and/or pain in a joint at rest with pressure or on passive movement of the joint and joint manipulation. 68 joints were examined for tenderness. These joints include the temporomandibular (n = 2), sternoclavicular (n =2), acromioclavicular (n = 2), shoulder (n = 2), elbow (n = 2), wrist (n = 2), metacarpophalageal (n= 10), interphalangeal of thumb (n = 2), distal interphalangeal (n = 8), proximal interphalangeal (n =8), hip (n = 2), knee (n = 2), ankle mortise (n = 2), ankle tarsus (n = 2), metatarsophalangeal (n = 10), interphalangeal of great toe (n = 2), and proximal/distal interphalangeal of the toes (n = 8).

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 0.5 mg n=27 Participants Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 1 mg n=26 Participants Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Percent Change From Baseline in Tender Joint Count at Week 12	-8.5 percent change Standard Deviation 81.3	-31.4 percent change Standard Deviation 53.1	-42.0 percent change Standard Deviation 37.8

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Laquinimod 0.5 mg

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Laquinimod 1 mg

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=25 participants at risk Participants received 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 0.5 mg n=29 participants at risk Participants received 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks.	Laquinimod 1 mg n=28 participants at risk Participants received 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Ear and labyrinth disorders Vertigo	0.00% 0/25 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	3.4% 1/29 • Number of events 1 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	0.00% 0/28 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.
Infections and infestations Diverticulitis	0.00% 0/25 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	0.00% 0/29 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	3.6% 1/28 • Number of events 1 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.
Infections and infestations Pneumonia Mycoplasmal	0.00% 0/25 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	3.4% 1/29 • Number of events 1 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	0.00% 0/28 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.
Infections and infestations Tonsillitis	0.00% 0/25 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	3.4% 1/29 • Number of events 1 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	0.00% 0/28 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.
Psychiatric disorders Depression	0.00% 0/25 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	3.4% 1/29 • Number of events 1 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	0.00% 0/28 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.
Psychiatric disorders Suicidal Ideation	0.00% 0/25 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	3.4% 1/29 • Number of events 1 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	0.00% 0/28 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/25 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	0.00% 0/29 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.	3.6% 1/28 • Number of events 1 • Baseline up to Week 16 Safety analysis set included all randomized participants who received at least 1 dose of study drug. In this set, treatment was assigned based upon the treatment actually received regardless of the assigned treatment.

Other adverse events

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products R&D, Inc.

Phone: 1-888-483-8279

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Publication restrictions are in place

Restriction type: OTHER