SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE

New Phase 3 Trial for Moderate to Severe Lupus (SLE) Using Upadacitinib

NCT: NCT05843643 · Status: RECRUITING · Phase: Phase 3 · Sponsor: AbbVie · Started: 2023-07-19 · Est. Completion: 2027-10

Plain English Summary

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus is a Phase 3 clinical trial sponsored by AbbVie studying Systemic Lupus Erythematosus. This trial tests if upadacitinib is safe and effective for adults with moderate to severe lupus. It is for adults diagnosed with Systemic Lupus Erythematosus (SLE) who have active disease. Participants will take either upadacitinib or a placebo pill daily for 52 weeks, with regular clinic visits for assessments. Alternatives include current standard treatments for lupus, which may involve other medications or therapies. The trial aims to enroll 1000 participants.

Official Summary

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with a confirmed diagnosis of lupus for at least 6 months. Individuals with active lupus symptoms, including specific antibody markers and disease activity scores. Patients must be on stable background lupus medications (with some exceptions for corticosteroids). Those with certain types of lupus kidney disease, active neurological lupus, or a history of specific blood clots may not be eligible. This trial is studying Systemic Lupus Erythematosus, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if a higher percentage of patients taking upadacitinib show significant improvement in their lupus symptoms compared to those taking a placebo, as measured by a specific clinic The specific primary outcome measures are: Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response (At Week 52). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial is important because it investigates a new treatment option for lupus, aiming to fill a gap in managing this complex autoimmune disease with potentially fewer side effects than some existin As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Systemic Lupus Erythematosus, where improved treatment options are needed.

Investor Insight

AbbVie's upadacitinib, already approved for other conditions, is being tested for a large patient population with SLE, indicating a significant market opportunity and a competitive landscape for autoi Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of upadacitinib and how it compares to your current treatment. Understand that you will be randomly assigned to receive either the study drug or a placebo, and neither you nor your doctor will know which one you are getting. Be prepared for regular clinic visits, medical tests, and questionnaires to monitor your health and disease activity throughout the 52-week study period. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
* At Screening, must have at least one of the following:

  * antinuclear antibody (ANA) positive (titer \>= 1:80)
  * anti-double stranded deoxyribonucleic acid (dsDNA) positive
  * anti-Smith positive
* Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) \>= 6, of which \>= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as \>= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
* Physician's Global Assessment (PhGA) \>= 1 during screening period.
* On stable background treatment for \>= 60 days prior to Baseline (with the exception of oral corticosteroid \[OCS\], which must be at a stable dose for \>=14 days prior to Baseline) with

  * antimalarial(s) \[hydroxychloroquine \<= 400 mg daily, chloroquine \<= 500 mg daily, quinacrine \<= 100 mg daily\];
  * and/or prednisone (or prednisone-equivalent) (\<= 20 mg daily);
  * and/or no more than 1 of the following: azathioprine (\<= 150 mg daily), 6-mercaptopurine (\<= 150 mg daily), mycophenolate mofetil (\<= 2 g daily), mycophenolate sodium \<= 1,440 mg/day, leflunomide (\<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (\<= 23.7 mg twice daily), methotrexate (\<= 25 mg weekly), or mizoribine (\<= 150 mg daily).

Exclusion Criteria:

* Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
* Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
* Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
* Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
* History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
* Pregnancy, breastfeeding, or considering becoming pregnant during the study.
* Clinically relevant or significant ECG abnormalities at Screening.
* Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05843643?

NCT05843643 is a Phase 3 INTERVENTIONAL study titled "Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus." It is currently recruiting and is sponsored by AbbVie. The trial targets enrollment of 1000 participants.

What conditions does NCT05843643 study?

This trial investigates treatments for Systemic Lupus Erythematosus. The primary condition under study is Systemic Lupus Erythematosus.

What treatments are being tested in NCT05843643?

The interventions being studied include: Upadacitinib (DRUG), Placebo (DRUG). Oral Tablets

What does Phase 3 mean for NCT05843643?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT05843643?

This trial is currently "Recruiting." It started on 2023-07-19. The estimated completion date is 2027-10.

Who is sponsoring NCT05843643?

NCT05843643 is sponsored by AbbVie. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05843643?

The trial aims to enroll 1000 participants. The trial is currently recruiting and accepting new participants.

How is NCT05843643 designed?

This is a interventional study, uses randomized allocation, follows a sequential design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT05843643?

The primary outcome measures are: Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response (At Week 52). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05843643 being conducted?

This trial is being conducted at 20 sites, including Chandler, Arizona; Flagstaff, Arizona; Gilbert, Arizona; Glendale, Arizona and 16 more sites (United States).

Where can I find official information about NCT05843643?

The official record for NCT05843643 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05843643. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05843643 testing in simple terms?

This trial tests if upadacitinib is safe and effective for adults with moderate to severe lupus. It is for adults diagnosed with Systemic Lupus Erythematosus (SLE) who have active disease.

Why is this trial significant?

This trial is important because it investigates a new treatment option for lupus, aiming to fill a gap in managing this complex autoimmune disease with potentially fewer side effects than some existin As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT05843643?

Common side effects may include infections (like colds or flu), acne, and headaches. There is a risk of more serious infections, blood clots, or changes in blood cell counts. The study is 'double-blinded,' meaning neither you nor your doctor knows if you are receiving the active drug or a placebo, which is a standard safety measure. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05843643?

Ask your doctor about the specific risks and benefits of upadacitinib and how it compares to your current treatment. Understand that you will be randomly assigned to receive either the study drug or a placebo, and neither you nor your doctor will know which one you are getting. Be prepared for regular clinic visits, medical tests, and questionnaires to monitor your health and disease activity throughout the 52-week study period. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05843643 signal from an investment perspective?

AbbVie's upadacitinib, already approved for other conditions, is being tested for a large patient population with SLE, indicating a significant market opportunity and a competitive landscape for autoi This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will take either upadacitinib or a placebo pill daily for 52 weeks, with regular clinic visits for assessments. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.