M19-130 A Phase 2 Study Investigating ABBV-105 and Upadacitinib in SLE
Research type
Research Study
Full title
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
IRAS ID
272481
Contact name
Ben Parker
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2019-000638-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 16 days
Research summary
Systemic Lupus Erythematosus (SLE) is a long-term, autoimmune disease that causes inflammation (swelling) and pain in connective tissues and affects several organs. In addition to affecting skin and joints, SLE can also affect the kidneys, lungs, heart, and brain. Some symptoms of SLE are extreme tiredness, discomfort, fever, loss of appetite, joint pain, muscle pain, and weakness. Skin problems like a flat, red rash across cheeks and bridge of nose, called “butterfly rash” can occur. About one-third of people with SLE develop kidney disease. The purpose of the study is to see if ABBV-105 and upadacitinib, given alone or in combination are safe and effective to treat signs and symptoms of SLE.
ABBV-105, and upadacitinib are oral investigational drugs being studied, in subjects with SLE, alone or in combination. The study consists of 5 treatment groups:
Group 1: Upadacitinib (Dose A) and ABBV-105 (Dose A)
Group 2: Upadacitinib (Dose B) and ABBV-105 (Dose A)
Group 3: ABBV-105 (Dose A) and Placebo for Upadacitinib
Group 4: Upadacitinib (Dose A) and Placebo for ABBV-105
Group 5: Placebo for ABBV-105 and Placebo for Upadacitinib
The study is conducted at approximately 140 sites worldwide on 325 adult subjects.ABBV-105 is an oral capsule and upadacitinib is an oral tablet. Participants will be given ABBV-105, upadacitinib, ABBV-105 plus upadacitinib or placebo, depending on the group assignment. There is a 1 in 5 chance that participants will be assigned to placebo. There is a 42-day screening period, which includes 1 visit to the research center, a 48-week treatment period, which includes 14 visits to the research center, and a recommended 30-day follow up phone call.
Participants will undergo tests like chest x-rays, electrocardiograms, physical exams, joint assessments, questionnaires, blood tests, and biomarker (blood sample) research. Safety evaluations will occur throughout the study.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0319
Date of REC Opinion
23 Apr 2020
REC opinion
Further Information Favourable Opinion