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AMG 139

Phase 1

Crohn's Disease | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: May 10, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

AMG 139 · 2 trials · 2 indications

Phase 1 2
NCT01258205Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease SubjectsCrohn's Disease
COMPLETED48 Analytics
NCT01094093Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe PsoriasisPsoriasis
COMPLETED73 Analytics
PHASE1COMPLETED
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Crohn's DiseaseUnlock trial analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139
36 weeks

Secondary Endpoints

Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD
36 weeks
Characterization of the pharmacokinetics (PK) of AMG 139
16-24 weeks
Psoriasis Activity and Severity Index (PASI) scores (Part B only)
16-24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part BEXPERIMENTALOne dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.
Part AEXPERIMENTALThree dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.

Interventions

NameTypeDescription
AMG 139DRUGFour dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: Part A - Healthy Subjects: * Healthy male or female of non-reproductive potential subjects between 18 to 45 years-of-age * Body mass index (BMI) between 18 and 32 kg/m2 * Normal or clinically acceptable physical examination, clinical laboratory values, and ECG * Additional incl...

Countries:United StatesAustraliaNew Zealand
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Frequently asked questions about AMG 139

What is AMG 139 used for?

AMG 139 is an investigational small molecule being studied for the treatment of Crohn's Disease and Psoriasis. It is in Phase 1 clinical development and is not approved by the FDA. The drug is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in clinical trials.

Who makes AMG 139?

AMG 139 is being developed by AstraZeneca PLC, which trades under the ticker symbol AZN. The drug is currently in Phase 1 clinical development for gastrointestinal and dermatological indications.

What phase is AMG 139 in?

AMG 139 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed to evaluate its safety and tolerability in healthy subjects and patients with psoriasis or Crohn's disease.

What clinical trials is AMG 139 in?

AMG 139 has been studied in two completed Phase 1 clinical trials. NCT01094093 evaluated safety and tolerability in healthy subjects and subjects with moderate to severe psoriasis. NCT01258205 evaluated multiple ascending doses in healthy subjects and subjects with Crohn's disease.

Is AMG 139 the same as another drug?

AMG 139 is also known by its code name AMG 139. No other alternative names have been reported for this investigational drug. It is being developed by AstraZeneca for potential use in Crohn's disease and psoriasis.