Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis

NCT ID: NCT00757042

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-18
• Study Completion Date: 2011-01-05

Brief Summary

This study is a single dose escalation study of tezepelumab (AMG 157) in healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B). The purpose of the study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of tezepelumab.

Conditions

Atopic Dermatitis; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tezepelumab

Participants will receive a single dose of tezepelumab administered subcutaneously or intravenously. The starting dose will be 2.1 mg tezepelumab.

Group Type: EXPERIMENTAL

Tezepelumab

Intervention Type: DRUG

Administered by subcutaneous or intravenous injection

Placebo

Participants will receive matching placebo administered subcutaneously or intravenously.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo administered by subcutaneous or intravenous injection.

Interventions

Tezepelumab

Administered by subcutaneous or intravenous injection

Intervention Type: DRUG

Placebo

Matching placebo administered by subcutaneous or intravenous injection.

Intervention Type: DRUG

Other Intervention Names

AMG 157; Tezspire

Eligibility Criteria

Inclusion Criteria

• Subject must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures
• Subjects must be aged between 18 and 45 years, inclusive (Part A only)
• Female subjects must be of non-reproductive potential
• Male subjects with partners of childbearing potential should inform their partner of their participation in this clinical study and use highly effective methods of birth control during the study
• Healthy subjects must have a body mass index (BMI) between 18 to 32 kg/m^2, inclusive
• Subject must have normal or clinically acceptable physical examination, clinical laboratory tests and electrocardiogram (ECG) results
• For Part B, subject must have active atopic dermatitis (AD) affecting ≥ 10% body surface area; Eczema Area and Severity Index (EASI) score ≥ 15, aged between 18 and 60 years, inclusive and BMI between 18 and 35 kg/m^2, inclusive

Exclusion Criteria

• Subject who has history or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Investigator in consultation with the Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Subject who has evidence of any active or suspected bacterial, viral, fungal or parasitic infections within the past 30 days prior to randomization
• Subject who has known positive tuberculin skin test or recent (within 6 months from randomization) exposure to an individual with active tuberculosis
• Subject who has history of malignancy within 5 years before randomization
• Subject who has history of significant dermatological conditions (except for atopic dermatitis in Part B)
• Subject who has previously received any investigational drug (or is currently using an investigational device) within 30 days prior to randomization
• Subject who has tested positive for drugs and/or alcohol use at screening or before randomization
• Female subjects who are pregnant or lactating
• Subject who has used nicotine or tobacco containing products during 6 months before randomization and during the study (except for Part B below)
• Subject has known type I/II diabetes
• Subject used nonprescription drugs within 14 days prior to randomization and during the study
• Subject used any cytotoxic or immunosuppressive drugs with 30 days or 5 half-lives prior to randomization and during the study
• Subject previously received a monoclonal antibody
• Subject donated blood or had loss of blood of equal to or greater than 500 mL with 2 months of screening
• Subject positive for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies
• Subject has any condition that might compromise informed consent or compliance to the protocol
• Subject who has concurrent skin disease (eg, acne) of such severity in the study area that it could interfere with study evaluation;
• Subject who has active or recent skin infections (within 7 days of randomization);
• Subject who has received phototherapy (eg, ultraviolet [UV] A, UVB) known or suspected to have an effect on AD within 6 weeks prior to randomization;
• Subject who has received corticosteroids by other than topical, inhaled or intranasal delivery within 4 weeks prior to randomization;
• Subject who has been treated with topical calcineurin inhibitors within 14 days prior to randomization;
• Subject who uses any medications that interfere with blood coagulation (eg nonsteroidal anti-inflammatory drugs [NSAIDs]) or wound healing within 7 days or 5 half-lives (whichever is longer) prior to enrolling into the study and for the duration of the study.
• Subject who smokes more than 10 cigarettes per day within the 6 months prior to randomization and during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Parnes JR, Sullivan JT, Chen L, Dias C. Pharmacokinetics, Safety, and Tolerability of Tezepelumab (AMG 157) in Healthy and Atopic Dermatitis Adult Subjects. Clin Pharmacol Ther. 2019 Aug;106(2):441-449. doi: 10.1002/cpt.1401. Epub 2019 Mar 23.

Reference Type: BACKGROUND

PMID: 30779339 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20070620

Identifier Type: -

Identifier Source: org_study_id