Lupus drug trial halted early: what we know
NCT ID NCT05306574
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
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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 Hide 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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Get notified about this 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
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Anniston, Alabama Site
Anniston, Alabama, 36207, United States
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Barranquilla site
Barranquilla, 080002, Colombia
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Barranquilla site
Barranquilla, 080020, Colombia
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Batangas Site
Batangas, 4217, Philippines
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Baytown Site
Baytown, Texas, 77521, United States
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Bucaramanga site
Bucaramanga, 680003, Colombia
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Budapest Site
Budapest, 1097, Hungary
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Bydgoszcz Site
Bydgoszcz, 85-065, Poland
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Bydgoszcz Site 2
Bydgoszcz, 85-168, Poland
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Bydgoszcz Site 3
Bydgoszcz, 85-605, Poland
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Bytom Site
Bytom, 41-902, Poland
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Cagayan de Oro City Site
Cagayan de Oro, 9000, Philippines
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Caguas Site
Caguas, 00725, Puerto Rico
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Ciudad Autonoma Buenos Aires Site 2
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
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Ciudad de Mexico Site
Mexico City, 06700, Mexico
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Colleyville, Texas Site
Colleyville, Texas, 76034, United States
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Cordoba Site
Córdoba, X5000AVE, Argentina
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Cuernavaca Site
Cuernavaca, 62448, Mexico
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Debrecen Site
Debrecen, 4032, Hungary
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Garran Site
Garran, Austl. Cap. Terr., 2605, Australia
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Grand Blanc Site
Grand Blanc, Michigan, 48439, United States
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Guadalajara Site
Guadalajara, 44670, Mexico
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Guatemala site
Guatemala City, Guatemala
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Gyula Site
Gyula, 5700, Hungary
-
Houston Site
Houston, Texas, 77084, United States
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Katowice Site
Katowice, 40-748, Poland
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Koeln Site
Cologne, North Rhine-Westphalia, 50937, Germany
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Krakow Site 1
Krakow, 31-501, Poland
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Lodz Site
Lodz, 90-368, Poland
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Los Baños Site
Los Baños, 4030, Philippines
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Makati City Site
Makati City, 1229, Philippines
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Malbork Site
Malbork, 82-200, Poland
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Manila Site
Manila, 1012, Philippines
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Medellin Site 1
Medellín, 050025, Colombia
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Medellin site 2
Medellín, 50021, Colombia
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Mexico Site 2
México, 67000, Mexico
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Mexico site 1
México, 06760, Mexico
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Miami, FL Site
Miami, Florida, 33014, United States
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Mission Hills Site
Mission Hills, California, 91345, United States
-
Monteria site
Montería, 230002, Colombia
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Muenster Site
Münster, North Rhine-Westphalia, 48149, Germany
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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
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Quilmes Site
Quilmes, Buenos Aires, B1878DVB, Argentina
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Rosario Site
Rosario, Santa Fe Province, S2000PBJ, Argentina
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Ruse Site
Rousse, 7002, Bulgaria
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San Juan Site
San Juan, 5400, Argentina
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San Juan Site
San Juan, 00917, Puerto Rico
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San Miguel de Tucuman Site 1
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
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San Miguel de Tucuman Site 2
San Miguel de Tucumán, Tucumán Province, T4000ICL, Argentina
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Santiago Site 1
Santiago, 7500710, Chile
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Santiago Site 2
Santiago, 8330336, Chile
-
Santiago Site 3
Santiago, 7501126, Chile
-
Santiago Site 4
Santiago, 7500010, Chile
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Sevilla Site 1
Seville, 41010, Spain
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Sevilla Site 2
Seville, 41013, Spain
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Sevlievo Site
Sevlievo, 5400, Bulgaria
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Sofia Site 1
Sofia, 1431, Bulgaria
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Sofia Site 3
Sofia, 1612, Bulgaria
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Sofia Site 4
Sofia, 1463, Bulgaria
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Sofia Site 5
Sofia, 1463, Bulgaria
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Stara Zagora Site
Stara Zagora, 6000, Bulgaria
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Szczecin Site
Szczecin, 71-252, Poland
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Tampa, Florida Site
Tampa, Florida, 33765, United States
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Thousands Oaks Site
Thousand Oaks, California, 91360, United States
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Valencia Site
Valencia, 46017, Spain
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Waco Site
Waco, Texas, 76710, United States
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Warszawa Site
Warsaw, 04-305, Poland
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Warszawa Site 2
Warsaw, 00-874, Poland
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Warszawa Site 3
Warsaw, 02-637, Poland
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Wheaton, Maryland Site
Wheaton, Maryland, 20902, United States
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Wroclaw Site 2
Wroclaw, 50-556, Poland
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Other studies related to the condition(s) this trial covers.
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