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Clinical trial

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus

ID
Name
TAK-079-2001
Description
The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison with matching placebo, administered once every 3 weeks over a 12-week dosing period in participants with active SLE who are receiving stable background therapy for SLE.
Trial arms
Trial start
2018-11-26
Estimated PCD
2021-11-04
Trial end
2021-11-04
Status
Completed
Phase
Early phase I
Treatment
TAK-079
TAK-079 subcutaneous injection.
Arms:
TAK-079 135 mg, TAK-079 45 mg, TAK-079 90 mg
TAK-079 Placebo
TAK-079 placebo-matching subcutaneous injection.
Arms:
Pooled Placebo
Size
23
Primary endpoint
Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
From the study start to end of the study (up to Week 36)
Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)
From the study start up to end of the study (up to Week 36)
Percentage of Participants With ≥ 1 Adverse Event (AE) Leading to Treatment Discontinuation
From the study start up to end of the study (up to Week 36)
Eligibility criteria
Inclusion Criteria: 1. The participant been diagnosed with SLE as defined by either the 2012 Systemic Lupus International Collaborating Clinics or the American College of Rheumatology diagnostic criteria. 2. The participant has a systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score greater than or equal to (\>=) 6. 3. The participant is positive for anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies and/or anti-extractable nuclear antigens (ENA) antibodies. Exclusion Criteria: 1. The participant had an opportunistic infection less than or equal to (\<=)12 weeks before initial study dosing or is currently undergoing treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria. 2. The participant currently has, or recently had, an acute or chronic infection requiring one or more of the following interventions: Hospitalization \<=30 days before the screening visit. - Administered parenteral (IV or intramuscular) antibacterial, antiviral, antifungal, or antiparasitic agents \<=30 days before the screening visit. 3. The participant has drug-induced SLE or any other rheumatologic or autoimmune disease (excluding secondary Sjögren syndrome or mixed connective tissue disease).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2024-03-29

1 organization

1 product

3 indications

Organization
Millennium Pharmaceuticals
Product
TAK-079
Indication
Systemic Lupus Erythematosus
Indication
Lupus Erythematosus
Indication
Systemic