A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus (SLE)MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2019-000638-20-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 325
• 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 despite background therapy 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
• Background treatment, stable for 30 days, with prednisone (=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) and a single, but not multiple, additional immunosuppressant is permitted.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 315
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
• 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, if not currently benefiting from, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method