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Lupus drug belimumab may shield organs from damage, new study hopes to prove

NCT ID NCT07056621

Disease control Sponsor: Biomedical Research Foundation, Academy of Athens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is tracking 684 people with lupus to see if the drug belimumab can prevent serious organ damage (called BILAG A flares) better than standard care alone. Researchers are using real-world data from clinics in Greece, comparing patients on belimumab to those on usual treatments. The goal is to find out if belimumab changes the long-term course of lupus.

What this could mean

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

Active substance
belimumab
What this could lead to
If successful, this could show that belimumab helps prevent serious organ damage in lupus patients, supporting its use as a long-term disease control treatment.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It is also early-stage real-world evidence, not a definitive proof of effectiveness.

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.

Participants

About 684 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Adult systemic lupus erythematosus patients, receiving belimumab (Arm A) or standard-of-care treatment (Arms B and C).

Ages

18 years and older

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: * Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria * Age ≥ 18 years old * Time of follow-up ≥ 6 months * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4 * Physician Global Assessment (PGA) visual analogue score \> 1 Exclusion Criteria: * Patients with incomplete medical records or missing key variables * Patients with concomitant autoimmune disorders (excluding thyroid disease)

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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.

SLE - systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital 'Attikon'

    RECRUITING

    Athens, Attica, 12462, Greece

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