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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline of m19-130 (week 0) through week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline of m19-130 (week 0) through week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events
Secondary outcome measures
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 more

Side effects data

From 2020 Phase 2 trial • 242 Patients • NCT03682705
6%
UPPER RESPIRATORY TRACT INFECTION
2%
COUGH
2%
ARTHRALGIA
2%
ERYTHEMA
100%
80%
60%
40%
20%
0%
Study treatment Arm
ELS Placebo/UPA Placebo
UPA 15 mg/ELS 60 mg
ELS 60 mg/UPA Placebo
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
~9670
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
954 Previous Clinical Trials
500,920 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,754 Total Patients Enrolled

Media Library

Elsubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04451772 — Phase 2
Lupus Research Study Groups: Part 1: Elsubrutinib Dose A and Upadacitinib Dose A, Part 3: Elsubrutinib Dose A and Upadacitinib Placebo, Part 2: Elsubrutinib Dose A and Upadacitinib Dose B, Part 4: Elsubrutinib Placebo and Upadacitinib Dose A
Lupus Clinical Trial 2023: Elsubrutinib Highlights & Side Effects. Trial Name: NCT04451772 — Phase 2
Elsubrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04451772 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study allow those over 20 years of age to participate?

"For this medical study, eligibility requires participants to be under 65 and above legal age."

Answered by AI

Is there an open call for participants in this experiment?

"As per the information on clinicaltrials.gov, this experiment is not presently accepting patients. It was initially advertised on July 27th 2020, but has been updated most recently November 9th 2022. At present there are 143 other trials recruiting participants across the country."

Answered by AI

How might Elsubrutinib pose a risk for individuals?

"The safety of Elsubrutinib is relatively well-established, thus giving it a score of 2. This drug has been tested in Phase 2 trials and there are data points to support the assertion that it is secure for use but none yet verifying its efficacy."

Answered by AI

How many individuals are being administered the experimental therapy in this clinical trial?

"At present, there is no recruitment for this medical trial. Initially posted on July 27th 2020 and last updated on November 9th 2022, the study has been suspended in its current incarnation. However, those seeking to contribute to clinical research can find 122 trials related lupus erythematosus systemic or 21 studies involving Elsubrutinib that are actively recruiting participants."

Answered by AI

Is my profile compatible with the criteria for this clinical trial?

"This clinical trial seeks enrolment from 260 individuals aged 18 to 65 suffering from lupus erythematosus, systemic. The inclusion criteria requires participants have already taken part in Study M19-130 and their SLE must be stable during the study period. Additionally, they should not possess laboratory or clinical characteristics that would lead to discontinuation according to those previously established in the randomized control trail of elsubrutinib, upadacitinib and ABBV-599 combination or matching placebo."

Answered by AI

To what extent have other researchers explored the effects of Elsubrutinib?

"Presently, there are 21 active clinical trials using Elsubrutinib; 14 of these studies have reached Phase 3. Multiple sites in Central Singapore are offering this medication to patients, but it is available at 3924 different locations globally."

Answered by AI

What is the customary purpose of Elsubrutinib?

"Elsubrutinib is an appropriate systemic therapy for individuals living with rheumatoid arthritis, as well as those being treated with methotrexate."

Answered by AI

How far-reaching is the distribution of this clinical experiment?

"The trial is accessible at 33 different sites, such as Qualmedica Research, LLC /ID# 227817 in Evansville, Allegheny Health Network Research Institute /ID# 245086 in Pittsburgh and St. Josephs Health Care Centre /ID# 221873 located in London."

Answered by AI

Does this research offer an innovative approach to the topic?

"Elsubrutinib's clinical trials have been a global affair, with 54 countries and 953 cities hosting 21 live studies. The earliest trial for the drug was sponsored by AbbVie in 2015; it concluded its Phase 3 stage after enrolling 1629 participants. Since then, additional 21 investigational trials have reached completion."

Answered by AI
~40 spots leftby Apr 2025