TAK-881 for Healthy Adults

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must not be taking: Biologics, Vaccines, Investigational products, others

Disqualifiers: Blood/clotting disorder, Liver, Heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

64 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements to participate in this trial.

What data supports the effectiveness of the drug TAK-881?

Research on a similar drug, the infliximab biosimilar CT-P13, shows it can be effective in treating Takayasu arteritis, a condition involving inflammation of blood vessels. Patients experienced improvements in disease activity and required lower doses of steroids, suggesting potential benefits for similar treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels. Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for healthy adults who can participate in a study lasting about 19 weeks. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conditions that would interfere with the study.

Inclusion Criteria

Must follow protocol-specified contraception guidance

Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m^2)

I haven't smoked or used nicotine products for at least 3 months.

Exclusion Criteria

History of alcohol or drug abuse within 2 years before dosing

History or presence of hypersensitivity or severe allergic reactions to blood or blood components

Pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAK-881 subcutaneous infusions with varying dosing schedules

8 weeks

Multiple visits for infusions on Days 1, 8, 15, 22, 29, 50, and 57

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TAK-881

Trial Overview The trial is testing TAK-881, which will be administered through subcutaneous infusions. Participants will first receive a lower dose on Day 1, followed by multiple infusions at higher doses to evaluate tolerability of different dosing schedules.

Participant Groups

Group I: Cohort 3, Schedule C: Treatment Arm 8: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner.

Group II: Cohort 3, Schedule B: Treatment Arm 7: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, SC injection, 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50 in ramp-up dosing manner.

Group III: Cohort 3, Schedule A: Treatment Arm 6: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, SC injection, 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50 in ramp-up dosing manner.

Group IV: Cohort 2, Schedule C: Treatment Arm 5: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.

Group V: Cohort 2, Schedule B: Treatment Arm 4: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, SC injection, 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50 in ramp-up dosing manner.

Group VI: Cohort 2, Schedule A, Treatment Arm 3: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, SC injection, 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50 in ramp-up dosing manner.

Group VII: Cohort 1, Schedule C, Treatment Arm 2: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.

Group VIII: Cohort 1, Schedule B, Treatment Arm 1: TAK-881 Experimental Treatment 2 Interventions

Participants will receive TAK-881, subcutaneous (SC) injection, 0.15 grams per kilogram (g/kg) on Day 1, 0.3 g/kg on Day 8, 0.6 g/kg on Days 22 and 50 in ramp-up dosing manner.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

References

1. England pubmed.ncbi.nlm.nih.gov

Predicting response to anti-TNFα therapy among patients with axial spondyloarthritis (axSpA): results from BSRBR-AS. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Prospective Observational Study on the Efficacy and Safety of Infliximab-Biosimilar (CT-P13) in Patients With Takayasu Arteritis (TAKASIM). [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Is tapering or discontinuation of biologic treatment in patients with radiographic and nonradiographic axial spondyloarthritis reasonable? : A local cohort study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Presentation and Disease Course of Childhood-Onset Versus Adult-Onset Takayasu Arteritis. [2019]