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Bruton's Tyrosine Kinase (BTK) Inhibitor
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
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 moreSide effects data
From 2023 Phase 3 trial • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
RASH
12%
INFLUENZA
12%
ARTHRALGIA
12%
URINARY TRACT INFECTION
12%
WEIGHT INCREASED
12%
FALL
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
12%
OROPHARYNGEAL PAIN
6%
HYPONATRAEMIA
6%
ORAL CANDIDIASIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
HEADACHE
6%
PNEUMONIA BACTERIAL
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
ASTHMA
6%
CONSTIPATION
6%
SJOGREN'S SYNDROME
6%
RHINORRHOEA
6%
HEPATIC STEATOSIS
6%
DEHYDRATION
6%
NAUSEA
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
VOMITING
6%
STAPHYLOCOCCAL INFECTION
6%
HAEMOGLOBIN DECREASED
6%
BONE CONTUSION
6%
HYPOKALAEMIA
6%
LIGAMENT RUPTURE
6%
PATELLA FRACTURE
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
COSTOCHONDRITIS
6%
STOMATITIS
6%
PERIPHERAL SWELLING
6%
LEUKOCYTOSIS
6%
PULMONARY EMBOLISM
6%
HERPES ZOSTER
6%
FEELING HOT
6%
LOCALISED INFECTION
6%
NASAL CONGESTION
6%
SEBORRHOEIC KERATOSIS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
6%
ERYTHEMA
6%
PHOTODERMATOSIS
6%
TACHYCARDIA
6%
HIP FRACTURE
6%
BACTERIAL SEPSIS
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CHEST PAIN
6%
FATIGUE
6%
CANDIDA INFECTION
6%
SKIN LACERATION
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
DYSPHAGIA
6%
SWELLING
6%
PNEUMONIA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
FEMUR FRACTURE
6%
SCRATCH
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ACUTE KIDNEY INJURY
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
PRURITUS
6%
FLANK PAIN
6%
SCIATICA
6%
BACK PAIN
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
OSTEOARTHRITIS
6%
DIZZINESS
6%
GLAUCOMA
6%
PHARYNGITIS
6%
OSTEOPENIA
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 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/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
1,040 Previous Clinical Trials
523,238 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,023 Total Patients Enrolled