Terminated/Withdrawn
Sponsor ID
20090403

Study to assess the long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Psoriasis

Sponsor ID
20090403
Clinicaltrials.gov ID
NCT01101100
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.

Additional Study Details

Phase
Phase 2
Product
AMG 827
Type
Interventional
Masking
None (Open Label)
Enrollment
181
Additional Study Details

Protocol Summary

Primary Outcome Measures

Adverse events

Timeframe: 362 weeks

Change in laboratory parameters and vital signs

Timeframe: 360 weeks

Secondary Outcome Measures

The proportion of subjects with a static physician’s global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)

Timeframe: 360 weeks

Percent improvement in Psoriasis Area and Severity Index (PASI)

Timeframe: 360 weeks

The proportion of subjects with a 50% improvement in PASI (PASI 50), PASI 75, PASI 90, and PASI 100

Timeframe: 360 weeks

Body surface area (BSA) involvement

Timeframe: 360 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Prahran, VIC, Australia, 3181
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Parkville, VIC, Australia, 3050
Status
Recruiting
Location
Research Site
Kogarah, NSW, Australia, 2217
Status
Recruiting
Location
Research Site
Waterloo, ON, Canada, N2J 1C4
Status
Recruiting
Location
Research Site
Markham, ON, Canada, L3P 1A8
Status
Recruiting
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