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New lupus drug shows promise in early trial

NCT ID NCT02472795

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study tested a new drug called cenerimod in 105 people with systemic lupus erythematosus (SLE), an autoimmune disease. The goal was to see if the drug could safely lower certain immune cells (lymphocytes) in the blood, which may help control the disease. Participants continued their usual lupus medications during the trial.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

105 people

The number who actually took part.

Started

Jun 2015

Finished

Feb 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies. * Enrolled participants must be treated with background SLE medications. Exclusion Criteria: * Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women. * Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Investigator Site

    Anniston, Alabama, 36207, United States

  • Investigator Site

    Clearwater, Florida, 33765, United States

  • Investigator Site

    Minsk, 220116, Belarus

  • Investigator Site

    Minsk, 223041, Belarus

  • Investigator Site

    Vitebsk, 210037, Belarus

  • Investigator Site

    Plovdiv, 4000, Bulgaria

  • Investigator Site

    Plovdiv, 4002, Bulgaria

  • Investigator Site

    Sofia, 1612, Bulgaria

  • Investigator Site

    Tbilisi, 0186, Georgia

  • Investigator Site

    Kemerovo, 650066, Russia

  • Investigator Site

    Kursk, 305007, Russia

  • Investigator Site

    Omsk, 644111, Russia

  • Investigator Site

    Orenburg, 460018, Russia

  • Investigator Site

    Smolensk, 214025, Russia

  • Investigator Site

    Vladimir, 600023, Russia

  • Investigator Site

    Vinnytsia, 21018, Ukraine

  • Investigator Site

    Vinnytsia, 21029, Ukraine

  • Investigator Site

    Zaporizhia, 69600, Ukraine

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