Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

NCT00867100 | Completed Phase 1 Results

• 1 other identifier: 20060279
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase 1 study will evaluate safety, tolerability, PK and PD of AMG 827 when administered as a single SC or IV dose.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43

  Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.

  Through day 43

• Part B: All Treatment Adverse Events Reported for Safety Evaluation

  This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.

  85 days

• Part A: All Treatment Adverse Events Reported for Safety Evaluation

  This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.

  Cohort 1-4 43 days, Cohort 5-8 64 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

140 mg SC

EXPERIMENTAL

140 mg SC PsO

Drug: 140 mg SC

350 mg SC

ACTIVE COMPARATOR

350 mg SC PsO

Drug: 350 mg SC

700 mg IV

EXPERIMENTAL

700 mg IV PsO

Drug: 700 mg IV

Interventions

700 mg IV DRUG

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

700 mg IV

350 mg SC DRUG

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

350 mg SC

Placebo DRUG

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

Placebo

140 mg SC DRUG

single SC or IV dose in healthy subjects (Part A) and subjects with moderate to severe psoriasis (Part B).

140 mg SC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part A:
• Able to provide written informed consent
• Healthy male or female between 18 to 45 years of age, inclusive at the time of screening
• Part B:
• years old inclusive at Screening
• Active but clinically stable, plaque psoriasis
• Psoriasis involving ≥ 10% of the body surface area
• A minimum PASI score of ≥ 10 obtained during the screening period

You may not qualify if:

• Part A:
• History or evidence of a clinically significant disorder (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Underlying condition that predisposes the subject to infections (eg, uncontrolled diabetes - HbA1c \> 7%, history of splenectomy)
• Part B:
• Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
• Evidence of skin conditions other than psoriasis (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
• Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Related Publications (1)

• Papp KA, Reid C, Foley P, Sinclair R, Salinger DH, Williams G, Dong H, Krueger JG, Russell CB, Martin DA. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012 Oct;132(10):2466-2469. doi: 10.1038/jid.2012.163. Epub 2012 May 24. No abstract available.

  PMID: 22622425 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Valeant Pharmaceuticals

binu.alexander@valeant.com

908

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: December 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share