A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03978520
• Date of registration: 03/06/2019
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) SLEek
• Scientific title: A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
• Date of first enrolment: July 25, 2019
• Target sample size: 341
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03978520
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Bulgaria, Canada, China, Colombia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant has clinical diagnosis of SLE at least 24 weeks prior to screening,
meeting at least 4 of the 11 revised Criteria for Classification of SLE according to
the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least
4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion
and 1 immunologic criterion.

- At Screening, must have at least one of the following:

- antinuclear antibody(ANA)+ (titer >= 1:80).

- anti-dsDNA+.

- anti-Smith+.

- SLEDAI-2K >= 6 despite background therapy as reported and independently adjudicated
(clinical score >= 4, excluding lupus headache and/or organic brain syndrome) at
Screening.

- If 4 points of the required entry points are for arthritis, there must also be a
minimum of 3 tender and 3 swollen joints.

- If participant has rash and PI considers it to be attributable to SLE,
participant must consent to skin photograph collection for adjudication.

- Score must be re-confirmed at the Baseline visit.

- Physician's Global Assessment (PhGA) >= 1 during screening period.

- Must be on background treatment, stable for 30 days, at Baseline and throughout the
study with antimalarial(s), prednisone (or prednisone equivalent) (<=20 mg),
azathioprine (<= 150 mg), mycophenolate (<2 g), leflunomide (<=20 mg), cyclosporine,
tacrolimus, and/or methotrexate (MTX) (<=20 mg).

- No combinations of the above with immunomodulators other than prednisone (or
equivalents) and antimalarials.

Exclusion Criteria:

- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or
equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus (SLE)

Intervention(s)

Drug: Placebo for upadacitinib

Drug: Placebo for Elsubrutinib

Drug: Elsubrutinib

Drug: Upadacitinib

Primary Outcome(s)

Achievement of SLE Responder Index (SRI)-4 and steroid dose <= 10 mg prednisone equivalent once a day (QD) [Time Frame: Week 24]

Secondary Outcome(s)

Change in Steroid Burden from Baseline [Time Frame: From Baseline (Week 0) to Week 24]

Number of flares by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI flare index [Time Frame: Up to Week 24]

Achievement of British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) [Time Frame: Up to Week 24]

Achievement of Lupus Low Disease Activity State (LLDAS) [Time Frame: Up to Week 24]

Achievement of SRI-4 [Time Frame: Up to Week 24]

Secondary ID(s)

2019-000638-20

M19-130

Source(s) of Monetary Support

Please refer to primary and secondary sponsors