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STRATOS 2

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting BETA2-Agonist

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222698
Enrollment
Unknown
Registered
2014-12-16
Start date
2014-12-16
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

Uncontrolled Asthma

Interventions

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

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Documented physician-diagnosed asthma. - Documented treatment with ICS at a total daily dose corresponding to 500 micrograms fluticasone propionate dry powder formulation equivalents) and a LABA - Morning pre-BD FEV1 value of 40 or more and <80% value (<90% for patients 12 to 17 years of age) of their PNV. - Post-BD reversibility of 12% or more and 200 mL or more in FEV1 - ACQ-6 score 1.5 or more

Exclusion criteria

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

Outcome results

None listed

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