Lupus drug sirolimus shows promise in phase 3 trial

NCT ID NCT04582136

Ongoing Disease control Sponsor: Chinese SLE Treatment And Research Group Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding sirolimus (rapamycin) to standard treatment helps control active lupus better than placebo. 146 adults with active lupus despite standard care will receive either sirolimus or placebo for 24 weeks, with an option to continue for another 24 weeks. The main goal is to see if more patients achieve a meaningful reduction in disease activity.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: sirolimus (rapamycin)
What this could lead to: If successful, sirolimus could offer a new treatment option for people with active lupus that is not well controlled by current therapies.
What could go wrong: This is a mid-stage trial with 146 participants, so results may not apply to everyone. Sirolimus has known side effects like mouth sores, infections, and increased cholesterol.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SYSTEMIC LUPUS ERYTHEMATOSUS

Contacts and locations

Locations

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100053, China
Shenzhen People's Hospital

Shenzhen, Guangdong, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Hospital of China Medical University

Shenyang, Liaoning, China
The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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