Your session is about to expire
← Back to Search
Bruton's Tyrosine Kinase (BTK) Inhibitor
Elsubrutinib + Upadacitinib for Lupus
Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline of m19-130 (week 0) through week 104
Summary
This trial is evaluating the combination of elsubrutinib and upadacitinib for the treatment of Systemic Lupus Erythematosus (SLE). Elsubrutinib and upadacitinib will be given orally, once daily for up to 56 weeks. The study will assess the change in disease symptoms.
Who is the study for?
Adults with moderately to severely active Systemic Lupus Erythematosus (SLE) who completed the M19-130 study without meeting any discontinuation criteria. They must be on a stable SLE treatment and cannot have active tuberculosis, need live vaccines during the trial, or have chronic infections or GI issues that increase perforation risk.
What is being tested?
The trial is testing oral elsubrutinib capsules and upadacitinib tablets alone or combined as ABBV-599 for their effect on SLE symptoms. It's double-blinded across four groups receiving different treatments for up to 56 weeks, involving monthly hospital visits for assessments.
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased infection risk, possible liver enzyme changes, blood count variations, and gastrointestinal complications among others based on similar medications' profiles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline of m19-130 (week 0) through week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline of m19-130 (week 0) through week 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Adverse Events
Secondary study objectives
Achievement of British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA)
Achievement of Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4
Change in Steroid Burden
+1 moreSide effects data
From 2020 Phase 2 trial • 242 Patients • NCT036827056%
UPPER RESPIRATORY TRACT INFECTION
2%
ARTHRALGIA
2%
COUGH
2%
ERYTHEMA
100%
80%
60%
40%
20%
0%
Study treatment Arm
ELS Placebo/UPA Placebo
ELS 60 mg/UPA Placebo
UPA 15 mg/ELS 60 mg
ELS 20 mg/UPA Placebo
ELS 5 mg/UPA Placebo
UPA 15 mg/ELS Placebo
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 4: Elsubrutinib Placebo and Upadacitinib Dose AExperimental Treatment2 Interventions
Participants will receive Elsubrutinib placebo and Upadacitinib Dose A QD.
Group II: Part 3: Elsubrutinib Dose A and Upadacitinib PlaceboExperimental Treatment2 Interventions
Participants will receive Elsubrutinib Dose A and Upadacitinib placebo QD.
Group III: Part 2: Elsubrutinib Dose A and Upadacitinib Dose BExperimental Treatment2 Interventions
Participants will receive Elsubrutinib Dose A and Upadacitinib Dose B QD.
Group IV: Part 1: Elsubrutinib Dose A and Upadacitinib Dose AExperimental Treatment2 Interventions
Participants will receive Elsubrutinib Dose A and Upadacitinib Dose A once daily (QD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elsubrutinib
2020
Completed Phase 2
~770
Upadacitinib
2014
Completed Phase 3
~11250
Placebo for Upadacitinib
2020
Completed Phase 3
~720
Placebo for Elsubrutinib
2020
Completed Phase 2
~190
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,394 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,179 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of a hole in your stomach or intestine, or your doctor thinks you are at high risk for this happening.
Research Study Groups:
This trial has the following groups:- Group 1: Part 3: Elsubrutinib Dose A and Upadacitinib Placebo
- Group 2: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A
- Group 3: Part 2: Elsubrutinib Dose A and Upadacitinib Dose B
- Group 4: Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.