Clinical Trial Overview: Evaluating Upadacitinib for Moderate to Severe Lupus (SLE)
Trial Name
SELECT-SLE (M23-699): A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus (SLE).

The Purpose of the Study
The SELECT-SLE program is a large-scale global research effort to determine if upadacitinib is safe and effective in reducing the signs and symptoms of Lupus. Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease where the immune system attacks various organs, causing inflammation and damage. This study aims to show that adding upadacitinib to standard therapy works better than standard therapy alone.

What is Upadacitinib?
Upadacitinib is an investigational drug for Lupus that belongs to a class of medicines called Janus kinase (JAK) inhibitors. It works by blocking specific signals in the immune system that lead to the inflammation seen in SLE. Upadacitinib is already approved in many countries for other conditions like rheumatoid arthritis and atopic dermatitis, and it is taken as an oral tablet once daily.

Who Can Participate?
You may be eligible for this study if you:

Are between 18 and 63 years old.

Have a confirmed diagnosis of SLE for at least 24 weeks.

Have moderately to severely active disease despite your current treatments.

Are currently on a stable dose of standard Lupus medications (like antimalarials, low-dose steroids, or certain immunosuppressants).

What to Expect During the Trial
Study Design: This is a randomized, double-blind study. Participants are assigned by chance (like a coin toss) to receive either upadacitinib (30 mg) or a placebo.

Primary Treatment Period: The first part of the study lasts 52 weeks.

Long-Term Extension: Participants who complete the first 52 weeks may be eligible for a Long-Term Extension (LTE) phase (Study 3), where all participants receive the active drug to monitor long-term safety and effectiveness.

Monitoring: You will visit the study site regularly for health check-ups, blood tests, and to complete questionnaires about your symptoms.

Why Participate?
Participation helps researchers learn if upadacitinib can provide a new oral treatment option for people with severe Lupus who do not get enough relief from current therapies. While there is no guarantee of personal benefit, participants receive study-related care and monitoring from Lupus specialists at no cost.