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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 44 to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 44 to week 52
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 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%
SEBORRHOEIC KERATOSIS
6%
HEADACHE
6%
NAUSEA
6%
HIP FRACTURE
6%
PHARYNGITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
HYPOKALAEMIA
6%
SJOGREN'S SYNDROME
6%
RHINORRHOEA
6%
PNEUMONIA BACTERIAL
6%
ASTHMA
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
CONSTIPATION
6%
HYPONATRAEMIA
6%
HEPATIC STEATOSIS
6%
DEHYDRATION
6%
PHOTODERMATOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
HAEMOGLOBIN DECREASED
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
FEELING HOT
6%
COSTOCHONDRITIS
6%
LEUKOCYTOSIS
6%
TACHYCARDIA
6%
STOMATITIS
6%
PATELLA FRACTURE
6%
ACTINIC KERATOSIS
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
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%
ACUTE KIDNEY INJURY
6%
HERPES ZOSTER
6%
PNEUMONIA
6%
OSTEOARTHRITIS
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
DERMATITIS ALLERGIC
6%
BACK PAIN
6%
DIZZINESS
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
VULVOVAGINAL MYCOTIC INFECTION
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
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 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 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
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
1,040 Previous Clinical Trials
522,579 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
163,364 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with lupus more than 24 weeks ago.My lupus is active with a score of 6 or more, mainly from symptoms, not lab tests.I've been on the same treatment for at least 30 days, except for oral steroids which I've had at a stable dose for 14 days.I am taking no more than one of the specified medications at or below the listed doses.I have tested positive for anti-dsDNA.I am taking 20 mg or less of prednisone daily.I have tested positive for anti-Smith antibodies.I am taking antimalarial medication within the specified daily limits.
Research Study Groups:
This trial has the following groups:- Group 1: Study 3- Low Disease Activity Upadacitinib (LDA) Dose A
- Group 2: Study 3- Open Label Upadacitinib Dose A
- Group 3: Study 1- Placebo
- Group 4: Study 3- Low Disease Activity Upadacitinib Dose B
- Group 5: Study 2- Upadacitinib Dose A
- Group 6: Study 3- Open Label Upadacitinib Dose B
- Group 7: Study 3- Upadacitininb Dose A
- Group 8: Study 2- Placebo
- Group 9: Study 3- No LDA Upadacitinib Dose A
- Group 10: Study 1- Upadacitinib Dose A
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.