A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or Refractory Systemic Sclerosi… (NCT06377228) | Clinical Trial Compass
WithdrawnPhase 1
A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) or Refractory Systemic Sclerosis (SSc)
Stopped: Business decision (no safety concerns)
United States0Started 2025-06-13
Plain-language summary
The main aim of the trial is to learn how well adults with refractory lupus nephritis (LN) or refractory systemic sclerosis (SSc) tolerate TAK-007 and to check for side effects (adverse events).
Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN or refractory SSc, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The participant must have a diagnosis of SLE fulfilling European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria.
✓. The participant must have a histologically proven glomerulonephritis (proliferative LN class III or IV, with or without the presence of class V, according to 2018 International Society of Nephrology/Renal Pathology Society \[ISN/RPS\] criteria).
✓. The participant must be positive for ANA at screening or by documented medical history, and at least one of the following autoantibodies at screening: anti-dsDNA or anti-Smith (Sm) antibody.
✓. The participant has had an inadequate response, defined as failure to improve within 12 weeks, based on investigator discretion, to at least 2 standard-of-care treatments for SLE (including glucocorticoids and immunosuppressive agents) OR at least 1 biologic treatment for SLE.
✓. The participant has a SLEDAI-2K total score ≥6.
✓. The participant must have a diagnosis of SSc fulfilling EULAR/ACR 2013 classification criteria.
✓. The participant must have an early disease: 5 years or less of disease duration since first non-Raynaud's sign or symptom.
✓. The participant must have evidence for presence of Interstitial Lung Disease (ILD) on HRCT imaging.
Exclusion criteria
✕. The participant has a history of drug-induced SLE.
✕. The participant has a current diagnosis of active or unstable neuropsychiatric lupus (e.g., cerebritis, cerebrovascular accident, and seizures). However, participants with mononeuritis multiplex or polyneuropathy can be included in the study.
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From first dose of LDC up to end of study (EOS) [up to Month 24]
2
Number of Participants With Dose Limiting Toxicities (DLTs)
✕. The participant has a history of catastrophic antiphospholipid syndrome or saddle embolism (antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 3 months is acceptable).
✕. The participant has a history or current diagnosis of other autoimmune diseases or current inflammatory joint or skin disease other than SLE that, in the opinion of the investigator and per sponsor assessment, could interfere with the inflammatory arthritis or skin assessments and confound the disease activity assessments.
✕. The participant has ppFVC ≤45% or DLCO ≤40% or requiring supplemental oxygen at screening.
✕. The participant has pulmonary arterial hypertension requiring active treatment.
✕. The participant has anti-centromere antibody.
✕. The participant has a history of severe scleroderma renal crisis OR scleroderma renal crisis within 6 months prior to Day 1.