A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
- Conditions
- Lupus10003816SLE
- Registration Number
- NL-OMON49791
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
• Adult male or female, 18 -65 years of age, inclusive, at Screening
• SLE by ACR 2012 or SLICC Diagnostic Criteria
• At Screening, must have at least one of the following:
* ANA+ (titer >= 1:80)
* anti-dsDNA+
* anti-Smith+
• SLEDAI-2K >= 6 as reported and independently adjudicated (excluding lupus
headache and/or organic brain syndrome) (clinical score >= 4) 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 subject has rash and PI considers it to be attributable to SLE, subject
must consent to skin photograph collection for adjudication.
* Score must be re-confirmed at the Baseline Visit
• Must be on background treatment, stable for 30 days prior to baseline, and
throughout the study with prednisone (or prednisone equivalent) (<=20mg),
antimalarials, azathioprine (<= 150mg), mycophenolate (<= 2g), leflunomide (<=
20mg) and/or methotrexate (MTX) (<= 20mg), cyclosporine, tacrolimus;
* The combination of background treatment with antimalarial(s) and/or
prednisone (or equivalent) is permitted.
* and a single, but not multiple, additional immunosuppressant from the list
above, is permitted
• Women of childbearing potential must not have a positive serum pregnancy test
at the screening visit and must have a negative urine pregnancy test at
baseline prior to the first dose of study drug. Note: Subjects with borderline
serum pregnancy tests at Screening must have a serum pregnancy test >= 3 days
later to document continued lack of positive result.
• Must not be using IV or IM corticosteroids greater than or equal to a 40 mg
prednisone-equivalent bolus within 30 days weeks of planned randomization
• Must not have active lupus nephritis (progressive Class IV or >1g/d
proteinuria) or have undergone induction therapy within the last 6 months.
• Must not have active neuropsychiatric SLE as defined by the CNS portion of
SLEDAI-2K (excluding lupus headache).
Subjects must be naïve or have discontinued the following prior to the first
dose of study drug per the applicable washout period below or should be at
least 5 times the mean terminal elimination half-life of a drug:
* >=6 months for Plasmapheresis
* >=3 months for Benlysta
* >=1 year for rituximab OR >= 6 months if B cells have returned to >= 50 B cells
per microliter
* >=3 months for cyclophosphamide
* >=4 weeks for abatacept, any anti-TNF therapy, and all other biologics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>SLE Responder Index (SRI)-4 and steroid dose <= 10 mg prednisone equivalent QD<br /><br>at Week 24.<br /><br>SLE Responder Index (SRI)-4 is defined as >= 4-point reduction in Systemic Lupus<br /><br>Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score without worsening<br /><br>of the overall condition (no worsening in Physician's Global Assessment (PhGA),<br /><br>< 0.3 point increase) or the development of significant disease activity in new<br /><br>organ systems (no new British Isles Lupus Assessment Group ([BILAG]) A or > 1<br /><br>new BILAG B).</p><br>
- Secondary Outcome Measures
Name Time Method