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Head-to-Head: which lupus drug works better?

NCT ID NCT07069972

Disease control Sponsor: Yipeng Liu Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two drugs, telitacicept and belimumab, for controlling systemic lupus erythematosus (SLE) in adults aged 18-65. Participants choose their treatment with their doctor, and researchers track how well each drug reduces lupus activity and kidney problems. The goal is to see which option is more effective and safer for managing this chronic autoimmune disease.

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 180 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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

Patients who were diagnosed with systemic lupus erythematosus through clinical examination at the First Affiliated Hospital of Shandong First Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, and the People's Hospital of Wuhan University

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: * Age range: 18 - 65 years old; * Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019; * The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement); * Has not responded well to hormone and/or immunosuppressant treatment, is intolerant or has recurrence, and is willing to accept tixocortinib/belimumab as a therapeutic drug. Exclusion Criteria: * Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, low gamma globulinemia, liver dysfunction; * eGFR \< 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation; * Pregnant women, or women who are about to become pregnant in the near future, or lactating women; * Participants who are simultaneously participating in other clinical studies; * Within 1 year before randomization, received B-cell targeted therapy (including belimumab); * During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.

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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

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

  • Qianfoshan Hospital

    Jinan, Shandong, 250000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.