NL-OMON49791
Completed
Phase 2
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 - M19-130
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Enrollment
- 9
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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