Lupus drug trial pulled before it even started
NCT ID NCT06456567
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test whether the drug telitacicept could help people with moderate-to-severe lupus better than a placebo. It was designed for people aged 12 to 70 with active lupus symptoms. However, the trial was withdrawn before enrolling any participants, so no results are available.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Expected to start
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Sep 2024
An estimate. Start dates often move.
- Finished
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Jan 2025
- Lead sponsor
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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
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12 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 definined 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. 4. History of arterial or venous thromboembolism or microangiopathy within 12 months prior to screening. 5. History of non-SLE disease requiring treatment with oral or parenteral. glucocorticosteroids for more than a total of 2 weeks within the last 24 weeks prior to screening.
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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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Hemet site
Hemet, California, 92543, United States
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Menifee site
Menifee, California, 92586, United States
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Rockford site
Rockford, Illinois, 61114, United States
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Stafford site
Stafford, Texas, 77477, United States
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Other studies related to the condition(s) this trial covers.
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