← Back to Search

Bruton's Tyrosine Kinase (BTK) Inhibitor

Upadacitinib for Systemic Lupus Erythematosus (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

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
  • Systemic Lupus Erythematosus

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose ≤ 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
Secondary study objectives
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 • 657 Patients • NCT03086343
24%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
RASH
12%
ACUTE RESPIRATORY FAILURE
12%
WEIGHT INCREASED
12%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
OROPHARYNGEAL PAIN
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
LIGAMENT RUPTURE
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
PHOTODERMATOSIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PNEUMONIA BACTERIAL
6%
STOMATITIS
6%
SKIN LACERATION
6%
HYPOKALAEMIA
6%
GLAUCOMA
6%
FEMUR FRACTURE
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
SWELLING
6%
SEBORRHOEIC KERATOSIS
6%
ACUTE KIDNEY INJURY
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
HERPES ZOSTER
6%
OSTEOARTHRITIS
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
INSOMNIA
6%
PRURITUS
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
ERYTHEMA
6%
COSTOCHONDRITIS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ASTHMA
6%
PATELLA FRACTURE
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
HEPATIC STEATOSIS
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD

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
~11250
Placebo for elsubrutinib
2018
Completed Phase 2
~590
Placebo for upadacitinib
2018
Completed Phase 3
~1520
Elsubrutinib
2020
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,023 Previous Clinical Trials
519,948 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
444 Previous Clinical Trials
160,434 Total Patients Enrolled
~55 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top