To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Not applicable
Secondary outcome
• SLE Responder Index (SRI)-4.
• British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment
(BICLA).
• Steroid burden, assessed as change from M19-130 Baseline.
• Number of mild, moderate or severe flares per patient-year (respectively and
overall) by Safety of Estrogens in Lupus Erythematosus National Assessment
(SELENA) SLEDAI flare index (SFI), assessed by number and types of flare per
subject compared across treatment groups .
Background summary
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated
with inflammation of multiple organ systems. This study will evaluate how well
elsubrutinib and upadacitinib given alone or as the ABBV-599 combination
(elsubrutinib/upadacitinib) works within the body, in participants who
completed study M19-130. This study will assess the change in disease symptoms.
Study objective
To evaluate the long-term safety and tolerability of elsubrutinib and
upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib)
combination in SLE subjects who have completed the M19-130 Phase 2 study.
Study design
This is a randomized double-blind placebo controlled long-term extension (LTE)
study.
Intervention
Participants will receive the following for up to 56 weeks:
Participants will receive oral elsubrutinib capsules or oral upadacitinib
tablets once daily for up to 56 weeks. Participants who were receiving
elsubrutinib and/or upadacitnib in M19-130 will continue to receive the same
treatment in this study. Participants who were receiving placebo in M19-130
will be re-randomized to one of the 4 treatment arms in this study.
Arm 1: Elsubrutinib Dose A and Upadacitinib Dose A
Arm 2: Elsubrutinib Dose A and Upadacitinib Dose B
Arm 3: Elsubrutinib Dose A and Upadacitinib Placebo
Arm 4: Elsubrutinib Placebo and Upadacitinib Dose A
Study burden and risks
There may be higher burden for participants in this trial compared to their
standard of care. Participants will attend monthly visits during the course of
the study at a hospital or clinic. The effect of the treatment will be checked
by medical assessments, blood tests, checking for side effects and completing
questionnaires.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
1. Subjects will have completed Study M19-130 (i.e., the preceding study of
elsubrutinib, upadacitinib, and ABBV599 [elsubrutinib/upadacitinib] combination)
2. Subjects must be on stable background treatment for SLE throughout the
study.
3. Subjects must understand and voluntarily sign and date an IEC/IRB- approved
informed consent
4. Women of childbearing potential (WOCBP) must have a negative urine pregnancy
test
5. Female subjects must be either postmenopausal, OR permanently surgically
sterile OR practicing at least one protocol-specified method of birth control
Exclusion criteria
1. Subjects may not have any active, chronic, or recurrent viral or
bacterialinfection.
2. Must not require vaccination with any live vaccine during study
participation.
3. Must not have a history of any malignancy except for successfully treated
Non-Melanoma Skin Cancer (NMSC) or localized carcinoma in-situ (CIS) of the
cervix.
4. Must not be a recipient of an organ transplant.
5. Women must not be pregnant, breastfeeding, or considering becoming pregnant
during the study and for at least 30 days after the last dose of study drug.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-001690-72-NL |
| ClinicalTrials.gov | NCT04451772 |
| CCMO | NL74175.028.20 |