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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

SELECT-SLE 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.Check my eligibility
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.See study design
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.

SELECT-SLE Trial 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.

SELECT-SLE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
Secondary outcome measures
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 • 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

SELECT-SLE 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
~9670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
501,390 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,109 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05843643 — Phase 3
Lupus Research Study Groups: Study 3- Open Label Upadacitinib Dose B, Study 3- Low Disease Activity Upadacitinib (LDA) Dose A, Study 1- Placebo, Study 3- Open Label Upadacitinib Dose A, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential harms could be associated with taking the Upadacitinib Dose A of Study 1?

"Our team has assigned a rating of 3 to Study 1- Upadacitinib Dose A as there is existing evidence for its efficacy and multiple trials have corroborated the medication's safety."

Answered by AI

Are additional participants being accepted for this trial?

"According to clinicaltrials.gov, this particular trial is not presently enrolling new patients. Although it was first published on June 30th 2023 and most recently updated April 25th of the same year, there are 142 alternative trials at the moment looking for participants."

Answered by AI

Do those who are fifty or over qualify to participate in this clinical trial?

"The entry requirements for this particular trial are restricted to individuals aged 18-63. Separately, there are 22 trials that cater specifically to minors and 122 tailored towards seniors."

Answered by AI

How many venues are hosting this investigation?

"This trial has already enrolled 258 patients, such as those at UF Health Rheumatology (ID# 255351) in Jacksonville, Lakes Research LLC (ID# 253621) in Miami, and HMD Research LLC (ID# 253595) in Orlando."

Answered by AI

Who else is applying?

What site did they apply to?
Trinity Universal Research Associates, Inc /ID# 253013
Accellacare - Salisbury /ID# 253608
DJL Clinical Research, PLLC /ID# 253620
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I need a better way to control Lupus symptoms. I would like to take less medicine and have less flares ups.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
2023. "Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05843643.
All > Systemic Lupus Erythematosus > Tucson
~667 spots leftby Oct 2026
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