A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

• Register: ClinicalTrials.gov
• Last refreshed on: 22 November 2021
• Main ID: NCT03724916
• Date of registration: 18/10/2018
• Prospective Registration: Yes
• Primary sponsor: Millennium Pharmaceuticals, Inc.
• Public title: A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)
• Scientific title: 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
• Date of first enrolment: November 26, 2018
• Target sample size: 58
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03724916
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Millennium Pharmaceuticals, Inc.

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Intervention(s)

Drug: TAK-079 Placebo

Drug: TAK-079

Primary Outcome(s)

Percentage of Participants With Greater Than or Equal to (>=) 1 Adverse Event (AE) Leading to Treatment Discontinuation [Time Frame: Up to Week 36]

Number of Participants With Grade 3 or Higher TEAEs [Time Frame: Up to Week 36]

Number of Participants who Experience at Least one Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) [Time Frame: Up to Week 36]

Secondary Outcome(s)

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 [Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose]

Number of Participants With Change From Baseline in (Cluster of Differentiation 38) CD38 Expression Level and Receptor Occupancy [Time Frame: Baseline up to Day 85]

Change From Baseline in Cytokines Level [Time Frame: Baseline up to Day 85]

Cmax: Maximum Observed Plasma Concentration for TAK-079 [Time Frame: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose; Day 22 pre-dose and at multiple time points (up to 108 hours) post-dose; Days 43 and 64 pre-dose and at multiple time points (up to 5 hours) post-dose]

Number of Participants With Change From Baseline In Immune Cell Subsets [Time Frame: Baseline up to Day 85]

Number of Participants With Positive Anti-drug Antibodies [Time Frame: Baseline up to Day 85]

Secondary ID(s)

U1111-1220-2497

TAK-079-2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors