Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 557 in Adults With Psoriasis

NCT01493518 | Terminated Phase 1

• 1 other identifier: 20110105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to study the safety, tolerability and immunogenicity of AMG 557 following multiple subcutaneous dose administration in adults with moderate to severe psoriasis.

Conditions

Psoriasis

Keywords

SAFETY; ADULT; PSORIASIS; INFLAMMATION

Outcome Measures

Primary Outcomes (1)

• Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 557

  28 weeks

Secondary Outcomes (3)

• Evaluate the efficacy of AMG 557 as measured by the proportion of subjects with a PASI 50, 75 and 90 at week 28

  28 weeks

• Measure the area under the serum concentration curve versus time of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis

  28 weeks

• Measure the peak serum concentration (Cmax) of AMG 557 after multiple dose administration in subjects with moderate to severe psoriasis

  28 weeks

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

Drug: AMG 557 or PLACEBO

AMG 557

EXPERIMENTAL

Drug: AMG 557 or PLACEBO

Interventions

AMG 557 or PLACEBO DRUG

Multiple subcutaneous doses of AMG 557 or Placebo on Days 1, 8, 15, 29, 43, 57 and 71.

AMG 557; PLACEBO

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must sign an Institutional Review Board (IRB)-approved informed consent form (ICF) before any study specific procedures.
• Diagnosis of moderate to severe plaque PsO for at least 6 months prior to screening as defined by:
• A minimum PASI score of ≥ 10 obtained at screening;
• Psoriasis involving ≥ 10% of the Body Surface Area (BSA) at screening.
• Received at least 1 previous phototherapy or systemic PsO therapy (but not within the 30 days before study drug administration), or has been a candidate to receive phototherapy or systemic PsO therapy in the opinion of the PI.
• Stable treatment without topical or systemic steroids, topical or systemic retinoids, vitamin D analogues (Dovenex), Psoralen Ultraviolet A (PUVA) therapy, Ultraviolet A (UVA) therapy or Ultraviolet B (UVB) therapy, methotrexate, or cyclosporine for at least 60 days prior to IP administration. Stable treatment of PsO involving scalp, axillae, or groin with topical corticosteroids of moderate strength will be allowed.
• Agrees to wear clothing that protects from sun exposure for the duration of the study.
• Agrees to use sunscreen (SPF of at least 30) on sun-exposed skin for the duration of the study.
• Male or female subjects between 18 and 55 years of age, inclusive at the time of screening.
• Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at screening, unless considered by the PI and the Amgen Medical Monitor to be at an appropriate value in the context of other measured safety parameters.
• Able and willing to complete entire study (including skin biopsies) according to study schedule.
• Additional criteria per protocol.

You may not qualify if:

• Diagnosis of guttate, pustular, or other non plaque forms of PsO.
• Evidence of skin conditions other than PsO (eg, eczema) during the screening period that would interfere with evaluations of the effect of IP on PsO.
• Previous receipt of any approved or investigational biologic agent for PsO or other medical conditions.
• Received PUVA therapy, UVA therapy or UVB therapy ≤ 30 days prior to IP administration.
• Treatment with any other systemic PsO therapy or oral or parenteral corticosteroids ≤ 30 days prior to IP administration.
• Use of high potency topical steroids, topical vitamin A or D analog preparations, or anthralin ≤ 30 days prior to IP administration (Note: stable doses \> 30 days of low or moderate strength topical steroids are permitted only on the scalp, axillae, and groin according to the package insert).
• Received topical cyclosporin or calcineurin inhibitors such as pimecrolimus (Elidel) and tacrolimus (Protopic) ≤ 30 days prior to IP administration.
• Received IV or oral calcineurin inhibitors such as tacrolimus (Prograf) ≤ 30 days prior to IP administration.
• Significant concurrent medical conditions at the time of screening or prior to randomization, including:
• Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 140 mm Hg or a screening diastolic blood pressure of greater than 90 mm Hg) confirmed by 2 separate measurements during 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;
• Open cutaneous ulcers;

Sponsors & Collaborators

• Amgen: lead

Study Sites (6)

Research Site

Birmingham, Alabama, 35233, United States

Location

Research Site

Reno, Nevada, 89511, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Research Site

Salt Lake City, Utah, 84107, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis; Inflammation

Interventions

AMG 557

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: December 16, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

US (6)