A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02194699
• Date of registration: 17/07/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma STRATOS2
• Scientific title: 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 ß2-Agonist
• Date of first enrolment: October 30, 2014
• Target sample size: 856
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02194699
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, Chile, Czech Republic, Czechia, Italy, Japan, Mexico, Philippines, Russian Federation, South Africa, Taiwan, Ukraine, United Kingdom, United States

Contacts

• Name: Christopher Brightling, MD
• Affiliation: Institute for Lung Health, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 12 -75

2. Documented physician-diagnosed asthma.

3. Documented treatment with ICS at a total daily dose corresponding to =500µg
fluticasone propionate dry powder formulation equivalents) and a LABA

4. Morning pre-BD FEV1 value of =40 and <80% value (<90% for patients 12 to 17 years of
age) of their PNV.

5. Post-BD reversibility of =12% and =200 mL in FEV1

6. ACQ-6 score =1.5

Exclusion Criteria:

1. Pulmonary disease other than asthma

2. History of anaphylaxis following any biologic therapy

3. Hepatitis B, C or HIV

4. Pregnant or breastfeeding

5. History of cancer

6. Current tobacco smoking or a history of tobacco smoking for = 10 pack-years

7. Previous receipt of tralokinumab



Age minimum: 12 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Uncontrolled Asthma

Intervention(s)

Biological: Experimental: Tralokinumab

Other: Placebo

Primary Outcome(s)

Annualised Asthma Exacerbation Rate (AAER) up to Week 52 [Time Frame: Baseline (Week 0) up to Week 52]

Secondary Outcome(s)

Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential [Time Frame: Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)]

Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage]) [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means) [Time Frame: Baseline (Week 0) and Week 52]

Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) [Time Frame: Baseline (Week 0) and Week 52]

Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry [Time Frame: Baseline (Week 0) up to Week 52]

Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 [Time Frame: At Week 52]

Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score [Time Frame: Baseline (Week 0) and Week 52]

Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations [Time Frame: Baseline (Week 0) up to Week 52]

Number of Patients With =1 Asthma Exacerbation up to Week 52 [Time Frame: Baseline (Week 0) up to Week 52]

WPAI+CIQ: Activity Impairment at Week 52 [Time Frame: At Week 52]

AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52 [Time Frame: Baseline (Week 0) up to Week 52]

Asthma-related Healthcare Encounters by Type up to Week 52 [Time Frame: Baseline (Week 0) up to Week 52]

Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 [Time Frame: Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up)]

Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52 [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score [Time Frame: Baseline (Week 0) and Week 52]

Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means) [Time Frame: Baseline (Week 0) and Week 52]

Secondary ID(s)

D2210C00008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/03/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02194699