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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 effects for adults with severe lupus.

Recruiting
18-63 years
All
Phase 3

Systemic Lupus Erythematosus (SLE) is a disease where the immune system attacks different parts of the body, causing inflammation. This study is testing a drug called upadacitinib to see if it helps adults with moderate to severe SLE. Participants will receive either the drug or a placebo, which looks like the drug but doesn't have any active medicine. The study is "double-blinded," meaning neither the participants nor the doctors know who gets the actual drug to ensure unbiased results. The study consists of four parts and may last up to 104 weeks. Participants will need to visit hospitals or clinics regularly for check-ups and to report any side effects. The study will enroll about 500 people per initial study phase across 320 sites worldwide.

  • Participants will be involved for up to 104 weeks, with regular hospital or clinic visits.
  • Eligible participants will receive daily doses of upadacitinib or placebo for the first 52 weeks.
  • There might be a higher treatment burden compared to regular care.
Study details
    Systemic Lupus Erythematosus

NCT05843643

AbbVie

17 May 2025

Step 1 Get in touch with the nearest study center
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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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