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Bruton's Tyrosine Kinase (BTK) Inhibitor

Upadacitinib for Lupus (SLEek Trial)

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, week 24
Awards & highlights

Summary

This trial is testing two drugs, elsubrutinib and upadacitinib, and their combination in people with severe lupus. The goal is to see if these treatments can reduce inflammation and symptoms by calming the immune system.

Eligible Conditions
  • Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
Secondary outcome measures
Change From Baseline in Daily Prednisone Dose at Week 24
Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24
+2 more

Side effects data

From 2023 Phase 3 trial • 613 Patients • NCT03086343
6%
URINARY TRACT INFECTION
5%
UPPER RESPIRATORY TRACT INFECTION
5%
NASOPHARYNGITIS
3%
HYPERTENSION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abatacept
Upadacitinib 15 mg

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Elsubrutinib placebo/upadacitinib 30 mgExperimental Treatment2 Interventions
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
Group II: Elsubrutinib 60 mg/upadacitinib placeboExperimental Treatment2 Interventions
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
Group III: ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg)Experimental Treatment2 Interventions
60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
Group IV: ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg)Experimental Treatment2 Interventions
60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
Group V: Elsubrutinib placebo/upadacitinib placeboPlacebo Group2 Interventions
Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~9670
Placebo for elsubrutinib
2018
Completed Phase 2
~590
Placebo for upadacitinib
2018
Completed Phase 3
~1470
Elsubrutinib
2020
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
983 Previous Clinical Trials
509,020 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
414 Previous Clinical Trials
151,551 Total Patients Enrolled
~56 spots leftby Sep 2025
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