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Lupus drug trial halted early: what we know

NCT ID NCT05306574

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested a weekly injection called telitacicept against a placebo in 91 people with moderate-to-severe lupus. The goal was to see if the drug could reduce disease activity and allow lower steroid doses. However, the trial was terminated early, so we have less information than planned.

What this could mean

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

Active substance
telitacicept (a biologic drug given as a weekly injection)
What this could lead to
If successful, telitacicept could offer a new treatment option to control lupus activity and reduce steroid use.
What could go wrong
This Phase 3 trial was terminated early with only 91 participants, so results are limited. The drug may not prove effective or safe in larger groups.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

91 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2025

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

12 to 70 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: 1. Age 12-70 years at screening. 2. Has a diagnosis of SLE for at least 6 months prior to the screening visit. 3. Meets the 2019 EULAR/ACR Classification criteria for SLE. 4. Moderately to severely active SLE defined by the following: 1. SELENA SLEDAI total score ≥6 points with clinical SLEDAI score ≥4 points at screening; 2. BILAG organ system scores of at least 1A or 2B at screening. 5. Clinical SLEDAI score of ≥4 at Day 0 prior to randomization. 6. At least one positive serologic parameter within the screening period. 7. Currently receiving at least one of the SOC SLE medications: oral corticosteroid, antimalarial and/or immunosuppressive agent. Exclusion Criteria: 1. Active lupus nephritis undergoing induction therapy or unstable renal diseases within 12 weeks prior to screening. 2. Active or unstable neuropsychiatric SLE. 3. Autoimmune or rheumatic disease other than SLE

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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

  • Anniston, Alabama Site

    Anniston, Alabama, 36207, United States

  • Barranquilla site

    Barranquilla, 080002, Colombia

  • Barranquilla site

    Barranquilla, 080020, Colombia

  • Batangas Site

    Batangas, 4217, Philippines

  • Baytown Site

    Baytown, Texas, 77521, United States

  • Bucaramanga site

    Bucaramanga, 680003, Colombia

  • Budapest Site

    Budapest, 1097, Hungary

  • Bydgoszcz Site

    Bydgoszcz, 85-065, Poland

  • Bydgoszcz Site 2

    Bydgoszcz, 85-168, Poland

  • Bydgoszcz Site 3

    Bydgoszcz, 85-605, Poland

  • Bytom Site

    Bytom, 41-902, Poland

  • Cagayan de Oro City Site

    Cagayan de Oro, 9000, Philippines

  • Caguas Site

    Caguas, 00725, Puerto Rico

  • Ciudad Autonoma Buenos Aires Site 2

    Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina

  • Ciudad de Mexico Site

    Mexico City, 06700, Mexico

  • Colleyville, Texas Site

    Colleyville, Texas, 76034, United States

  • Cordoba Site

    Córdoba, X5000AVE, Argentina

  • Cuernavaca Site

    Cuernavaca, 62448, Mexico

  • Debrecen Site

    Debrecen, 4032, Hungary

  • Garran Site

    Garran, Austl. Cap. Terr., 2605, Australia

  • Grand Blanc Site

    Grand Blanc, Michigan, 48439, United States

  • Guadalajara Site

    Guadalajara, 44670, Mexico

  • Guatemala site

    Guatemala City, Guatemala

  • Gyula Site

    Gyula, 5700, Hungary

  • Houston Site

    Houston, Texas, 77084, United States

  • Katowice Site

    Katowice, 40-748, Poland

  • Koeln Site

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Krakow Site 1

    Krakow, 31-501, Poland

  • Lodz Site

    Lodz, 90-368, Poland

  • Los Baños Site

    Los Baños, 4030, Philippines

  • Makati City Site

    Makati City, 1229, Philippines

  • Malbork Site

    Malbork, 82-200, Poland

  • Manila Site

    Manila, 1012, Philippines

  • Medellin Site 1

    Medellín, 050025, Colombia

  • Medellin site 2

    Medellín, 50021, Colombia

  • Mexico Site 2

    México, 67000, Mexico

  • Mexico site 1

    México, 06760, Mexico

  • Miami, FL Site

    Miami, Florida, 33014, United States

  • Mission Hills Site

    Mission Hills, California, 91345, United States

  • Monteria site

    Montería, 230002, Colombia

  • Muenster Site

    Münster, North Rhine-Westphalia, 48149, Germany

  • Murdoch Site

    Murdoch, Western Australia, 6150, Australia

  • Orange Site

    Orange, California, 92868, United States

  • Pleven Site

    Pleven, 5800, Bulgaria

  • Plovdiv Site

    Plovdiv, 4023, Bulgaria

  • Poznan SIte

    Poznan, 61-113, Poland

  • Poznan Site 2

    Poznan, 60-681, Poland

  • Poznań Site

    Poznan, 61-731, Poland

  • Quatre Bornes Site

    Quatre Bornes, 72218, Mauritius

  • Quilmes Site

    Quilmes, Buenos Aires, B1878DVB, Argentina

  • Rosario Site

    Rosario, Santa Fe Province, S2000PBJ, Argentina

  • Ruse Site

    Rousse, 7002, Bulgaria

  • San Juan Site

    San Juan, 5400, Argentina

  • San Juan Site

    San Juan, 00917, Puerto Rico

  • San Miguel de Tucuman Site 1

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • San Miguel de Tucuman Site 2

    San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina

  • Santiago Site 1

    Santiago, 7500710, Chile

  • Santiago Site 2

    Santiago, 8330336, Chile

  • Santiago Site 3

    Santiago, 7501126, Chile

  • Santiago Site 4

    Santiago, 7500010, Chile

  • Sevilla Site 1

    Seville, 41010, Spain

  • Sevilla Site 2

    Seville, 41013, Spain

  • Sevlievo Site

    Sevlievo, 5400, Bulgaria

  • Sofia Site 1

    Sofia, 1431, Bulgaria

  • Sofia Site 3

    Sofia, 1612, Bulgaria

  • Sofia Site 4

    Sofia, 1463, Bulgaria

  • Sofia Site 5

    Sofia, 1463, Bulgaria

  • Stara Zagora Site

    Stara Zagora, 6000, Bulgaria

  • Szczecin Site

    Szczecin, 71-252, Poland

  • Tampa, Florida Site

    Tampa, Florida, 33765, United States

  • Thousands Oaks Site

    Thousand Oaks, California, 91360, United States

  • Valencia Site

    Valencia, 46017, Spain

  • Waco Site

    Waco, Texas, 76710, United States

  • Warszawa Site

    Warsaw, 04-305, Poland

  • Warszawa Site 2

    Warsaw, 00-874, Poland

  • Warszawa Site 3

    Warsaw, 02-637, Poland

  • Wheaton, Maryland Site

    Wheaton, Maryland, 20902, United States

  • Wroclaw Site 2

    Wroclaw, 50-556, Poland

More trials for these conditions

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