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Upadacitinib for Lupus (SELECT-SLE Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
anti-double stranded deoxyribonucleic acid (dsDNA) positive
anti-Smith positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 44 to week 52
Awards & highlights
Pivotal Trial

Summary

This trial will assess if upadacitinib is a safe and effective treatment for SLE. 500 people will take part in this trial globally, taking either upadacitinib or a placebo in 3 sub-studies. Regular visits & assessments to check the effect of the treatment will be done.

Who is the study for?
Adults with moderate to severe Systemic Lupus Erythematosus (SLE) can join this trial. They must have been diagnosed at least 24 weeks ago, meet specific disease criteria including positive ANA and anti-dsDNA tests, and have a certain level of disease activity. Participants should be on stable SLE medication for some time before the study starts.
What is being tested?
The trial is testing Upadacitinib's safety and effectiveness in treating SLE compared to a placebo. It's double-blinded, meaning no one knows who gets the real drug or placebo. The study has three parts: two main studies where participants are randomly assigned treatment or placebo for 52 weeks, followed by a third study based on their initial results.
What are the potential side effects?
Possible side effects of Upadacitinib may include infections, headaches, nausea, high blood pressure, liver issues among others commonly seen in similar drugs used for arthritis conditions. Side effects will be monitored through regular medical check-ups.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tested positive for anti-dsDNA.
Select...
I have tested positive for anti-Smith antibodies.
Select...
I am taking antimalarial medication within the specified daily limits.
Select...
I am taking 20 mg or less of prednisone daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 44 to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 44 to week 52 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 British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
Secondary study objectives
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4
Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
+7 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%
OROPHARYNGEAL PAIN
12%
ARTHRALGIA
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
PATELLA FRACTURE
6%
ASTHMA
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%
COSTOCHONDRITIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PHOTODERMATOSIS
6%
PNEUMONIA BACTERIAL
6%
STOMATITIS
6%
HYPOKALAEMIA
6%
GLAUCOMA
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%
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%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SKIN LACERATION
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
SEBORRHOEIC KERATOSIS
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
ACTINIC KERATOSIS
6%
DERMATITIS ALLERGIC
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Study 3- Upadacitininb Dose AExperimental Treatment1 Intervention
Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Group II: Study 3- Open Label Upadacitinib Dose BExperimental Treatment1 Intervention
Participants who reach >= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.
Group III: Study 3- Open Label Upadacitinib Dose AExperimental Treatment1 Intervention
Participants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
Group IV: Study 3- No LDA Upadacitinib Dose AExperimental Treatment1 Intervention
Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Group V: Study 3- Low Disease Activity Upadacitinib Dose BExperimental Treatment1 Intervention
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Group VI: Study 3- Low Disease Activity Upadacitinib (LDA) Dose AExperimental Treatment1 Intervention
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Group VII: Study 2- Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib dose A once daily for 52 weeks.
Group VIII: Study 1- Upadacitinib Dose AExperimental Treatment1 Intervention
Participants will receive upadacitinib dose A once daily for 52 weeks.
Group IX: Study 1- PlaceboPlacebo Group1 Intervention
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Group X: Study 2- PlaceboPlacebo Group1 Intervention
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~11250

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,027 Previous Clinical Trials
519,885 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
448 Previous Clinical Trials
160,371 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05843643 — Phase 3
Lupus Research Study Groups: Study 3- Low Disease Activity Upadacitinib (LDA) Dose A, Study 3- Open Label Upadacitinib Dose A, Study 1- Placebo, Study 3- Open Label Upadacitinib Dose B, Study 3- Low Disease Activity Upadacitinib Dose B, Study 2- Upadacitinib Dose A, Study 3- Upadacitininb Dose A, Study 2- Placebo, Study 3- No LDA Upadacitinib Dose A, Study 1- Upadacitinib Dose A
Lupus Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05843643 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05843643 — Phase 3
~579 spots leftby Oct 2026
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