AMG 714 20060349 Multiple Dose Study in Moderate to Severe Psoriasis Subjects

NCT00443326 | Completed Phase 2

• 1 other identifier: 20060349
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigational drug AMG 714 will be given to 66 subjects with moderate to severe psoriasis to study safety, pharmacokinetics, and efficacy. Dose levels include 150mg and 300mg and will be given to each subject for a total of 6 doses. Each dose for each subject will be given once every 2 weeks. Subjects will followed for up to 300 days post the first dose of AMG 714.

Conditions

Psoriasis

Keywords

Psoriasis; PASI; Skin Biopsy; Human Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• Psoriatic Assessment Score Index

  First 85 Days

Secondary Outcomes (1)

• Safety and Tolerability

  Collected for 300 Days

Study Arms (1)

AMG 714

EXPERIMENTAL

AMG 714 will be given as a multiple dose regimen

Drug: AMG 714

Interventions

AMG 714 DRUG

Dosing Regimen is 6 Doses over 3 Months

AMG 714

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active but clinically stable, plaque psoriasis.
• Psoriasis involving greater than or equal to 10% of the body surface area
• A minimum PASI score of 10 obtained during the screening period.
• Received at least one previous phototherapy or systemic psoriasis therapy or have been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
• At least 18 years of age.
• Heterosexually active men and women must be willing to practice an effective method of contraception (as outlined in section 6.7) as determined by the investigator and sponsor for the duration of the study. This includes any washout period and the follow-up period.
• ALT and AST less than or equal to 2 x the upper limit of normal; hemoglobin greater than or equal to 10 g/dL (greater than or equal to 100 g/L in SI units); platelet count greater than or equal to 125,000 mm3 (greater than or equal to 125 x109/L in SI units); white blood cell count greater than or equal to 3,500 cells/mm3 (greater than or equal to 3.5 x109/L in SI units); serum creatinine less than or equal to 2 mg/dL (less than or equal to 177 μmol/L in SI units).
• Negative for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies.
• Capable of understanding and giving written, voluntary informed consent before study screening.

You may not qualify if:

• Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
• Evidence of skin conditions (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis.
• Clinically significant adverse event, infection, or laboratory toxicity, at the time of the screening visit or between the screening visit and study drug initiation that in the opinion of Amgen or the Investigator would preclude participation in the study.
• Clinically significant infection less than or equal to 30 days before the screening visit that in the opinion of Amgen or the Investigator would preclude participation in the study.
• Known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or recent (within 6 months) exposure to a patient with active tuberculosis.
• Any other known infectious process that would, in the investigator's discretion, interfere with the subject's ability to participate in the study.
• Significant concurrent medical conditions at the time of screening, including:
• Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 160 mm Hg or a screening diastolic blood pressure of greater than 100 mm Hg) confirmed by 2 separate measurements during the screening visit
• Myocardial infarction less than or equal to 52 weeks before the screening visit
• Unstable angina pectoris
• Congestive heart failure
• Steroid or oxygen dependent chronic obstructive pulmonary disease
• Diagnosis of multiple sclerosis or any other demyelinating disease
• Inadequately controlled diabetes mellitus, defined by glycohemoglobin greater than 7.0 at screening
• History of cancer (other than resected and surgically cured cervical cancer, cutaneous basal cell, squamous cell carcinoma) less than or equal to 5 years before the administration of first dose of investigational product

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

AMG-714

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 5, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: May 1, 2010
• Last Updated: January 20, 2016

Record last verified: 2015-12