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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.

D2212C00002 J-Phase II study

This is a phase II, multicenter, blinded within cohort, dose-escalation study to evaluate the safety and tolerability of two ascending doses of tralokinumab in Japanese patients aged ≥ 50 years with mild to moderate Idiopathic Pulmonary Fibrosis.

NCT ID

Therapeutic Area

Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor

Research Site

A Phase 2, Multicenter, Double-Blind within cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of multiple doses of CAT-354 (tralokinumab) in Japanese Patients with Idiopathic Pulmonary Fibrosis

adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.

Gender, Male/Female

Age Continuous

At lease one adverse events

At least one IP related adverse event

At least one adverse event of ≥ grade 3 severity

Death (grade 5 severity)

At least one serious adverse event

At least one serious and ≥ grade 3
severity event

At least one IP related serious adverse event

At least one event leading to IP discontinuation

Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.

Safety and tolerability primarily assessed by the number of patients with adverse events

Week 0 (post-dose)

Week 4 (pre-dose)

Week 12 (pre-dose)

Week 28

Week 40

Week 48

Serum tralokinumab concentration data will be summarized by treatment group.

Serum tralokinumab concentration data

Anti-drug antibody positive at baseline

Anti-drug antibody positive post-baseline

The incidence rate of positive serum antibodies to tralokinumab will be reported.

Immunogenecity

Overall Study

20 patients were randomized and received at least 1 dose of tralokinumab low dose, high dose, or placebo (tralokinumab low dose group: n=8, tralokinumab high dose group: n=8, placebo group: n=4).

Arms	Assigned Interventions
Experimental: Low Dose Investigational product Tralokinumab	Biological/Vaccine: tralokinumab cohort 1 Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
Experimental: High Dose Investigational product Tralokinumab	Biological/Vaccine: tralokinumab cohort 2 Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
Placebo Comparator: Placebo Placebo	-

D2212C00002 J-Phase II study

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator