FindTrial
Sign In

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting Beta 2-Agonist

A 52-Week, Open-Label, Multicentre Study to Evaluate the Safety of Tralokinumab in Japanese Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting Beta 2-Agonist

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223351
Enrollment
Unknown
Registered
2016-10-18
Start date
2016-10-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inadequately Controlled Asthma

Interventions

investigational material(s) Generic name etc : Tralokinumab(Genetical Recombination) INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Documented physician-diagnosed asthma 2. Documented treatment with inhaled corticosteroid (ICS) at a total daily dose corresponding to 500 microgram or more fluticasone propionate dry powder formulation equivalents and a long-acting beta-2 agonist (LABA) 3. Pre-bronchodilator (BD) forced expiratory volume at one second (FEV1) value of 40% or more of their Predicted Normal Value (PNV) 4. Asthma Control Questionnaire-6 (ACQ-6) score 1.5 or more

Exclusion criteria

Exclusion criteria: 1. Pulmonary disease other than asthma 2. History of anaphylaxis following any biologic therapy 3. Hepatitis B, C or HIV 4. Pregnant of breastfeeding 5. History or cancer 6. Current tobacco smoking or a history or tobacco smoking for 10 pack-years or more 7. Previous receipt of tralokinumab

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026