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Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

Study on oral Upadacitinib's effects in adults with lupus.

Recruiting
18-63 years
All
Phase 3

Study Details:

This study checks how safe and effective the drug upadacitinib is for adults with Systemic Lupus Erythematosus (SLE), a disease that causes inflammation in the body. Upadacitinib is already used for other diseases like rheumatoid arthritis. In this study, some participants will get the real drug and others will get a placebo (a pill with no medicine) to compare the effects.

The study is "double-blinded," meaning neither the participants nor the doctors know who gets the real drug. It's divided into three parts. In parts 1 and 2, people are randomly put into groups to get either the drug or placebo for 52 weeks, and part 3 follows after that.

  • Participation involves taking a pill daily for up to 104 weeks and regular hospital visits.
  • There may be more treatment tasks than usual care, like tests and questionnaires.
  • 500 participants are needed for parts 1 and 2 in about 320 locations worldwide.

Before joining, participants need to meet certain health conditions and can't have certain other diseases, be pregnant, or plan surgeries during the study.

Study details
    Systemic Lupus Erythematosus

NCT05843643

AbbVie

15 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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