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Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic Lupus Erythematosus

Testing ESK-001 for safety in lupus patients, Phase 2 trial.

Recruiting
18-70 years
All
Phase 2

Study Summary: This research is for people with Systemic Lupus Erythematosus (SLE), a disease where the immune system attacks the body. The study is testing a medicine called ESK-001 to see if it is safe and helps treat SLE. Some people will get ESK-001, and others will get a placebo, which is a fake treatment that looks like the real thing but has no medicine in it. This helps scientists see if the medicine really works.

Study Length: The study lasts about 57 weeks, starting with a 5-week screening, followed by 48 weeks of treatment, and a 4-week follow-up. After finishing, participants may join an open-label extension where everyone gets ESK-001.

  • Participants must have had SLE for more than 6 months and meet specific criteria.
  • Participants must be on certain treatments like low-dose steroids or antimalarial drugs.
  • Participants must not have other serious health issues that could affect the study.

Key Points: The study requires a long commitment (over a year), includes multiple visits, and participants may get a placebo. Discuss potential risks with your doctor before joining.

Study details
    SLE

NCT05966480

Alumis Inc

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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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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