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NCT00691964 Clinical Trial

Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00691964
Other study ID # M10-114
Secondary ID
Status Completed
Phase Phase 3
First received June 4, 2008
Last updated January 11, 2013
Start date May 2008
Est. completion date March 2009

Study information
Verified date January 2013
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis

Recruitment information / eligibility
Status Completed
Enrollment 347
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of Psoriasis for 6 mo.

- BSA 10%, PASI 12 or above, PGA 3 or above

Exclusion Criteria:

- Previous exposure to either etanercept or ABT-874

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• ABT-874
SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8
• etanercept
SQ injection 50 mg BIW
Drug:
• placebo
SQ placebo injections for ABT-874 and etanercept

Locations
Country Name City State
United States Site Reference ID/Investigator# 8447 Albuquerque New Mexico
United States Site Reference ID/Investigator# 8463 Alpharetta Georgia
United States Site Reference ID/Investigator# 8479 Arlington Heights Illinois
United States Site Reference ID/Investigator# 8461 Austin Texas
United States Site Reference ID/Investigator# 8464 Boston Massachusetts
United States Site Reference ID/Investigator# 8468 Cincinnati Ohio
United States Site Reference ID/Investigator# 8460 Cleveland Ohio
United States Site Reference ID/Investigator# 10542 Dallas Texas
United States Site Reference ID/Investigator# 8476 Denver Colorado
United States Site Reference ID/Investigator# 8473 East Windsor New Jersey
United States Site Reference ID/Investigator# 8462 Fresno California
United States Site Reference ID/Investigator# 8458 Goodlettsville Tennessee
United States Site Reference ID/Investigator# 8456 Greer South Carolina
United States Site Reference ID/Investigator# 9761 Hershey Pennsylvania
United States Site Reference ID/Investigator# 8452 Houston Texas
United States Site Reference ID/Investigator# 8467 Indianapolis Indiana
United States Site Reference ID/Investigator# 8449 Johnston Rhode Island
United States Site Reference ID/Investigator# 8480 Lake Oswego Oregon
United States Site Reference ID/Investigator# 8454 Los Angeles California
United States Site Reference ID/Investigator# 9641 Miami Florida
United States Site Reference ID/Investigator# 8457 New Brunswick New Jersey
United States Site Reference ID/Investigator# 8475 New York New York
United States Site Reference ID/Investigator# 8472 Norfolk Virginia
United States Site Reference ID/Investigator# 9762 Oklahoma City Oklahoma
United States Site Reference ID/Investigator# 8471 Philadelphia Pennsylvania
United States Site Reference ID/Investigator# 8469 Portland Oregon
United States Site Reference ID/Investigator# 9566 Portland Oregon
United States Site Reference ID/Investigator# 8448 Providence Rhode Island
United States Site Reference ID/Investigator# 8474 San Antonio Texas
United States Site Reference ID/Investigator# 8527 Schaumburg Illinois
United States Site Reference ID/Investigator# 9001 Skokie Illinois
United States Site Reference ID/Investigator# 8459 St. Louis Missouri
United States Site Reference ID/Investigator# 8478 Tucson Arizona
United States Site Reference ID/Investigator# 8482 Tyler Texas
United States Site Reference ID/Investigator# 8466 West Dundee Illinois

Sponsors (2)
Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott) Paragon Biomedical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12 12 Weeks No
Primary Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12 12 Weeks No
Secondary Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12 12 Weeks No
See also
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Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
Completed NCT05600036 - A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis Phase 2
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03614078 - A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis Phase 2
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Completed NCT02881346 - Efficacy and Tolerability of Enstilar® in Daily Practice
Recruiting NCT02611349 - Study to Evaluate the Long-Term Safety of IDP-118 Lotion in the Treatment of Plaque Psoriasis Phase 3
Completed NCT02251678 - Evaluate the Effect of Elimune Capsules Phase 1
Completed NCT01987843 - Dose-finding Study of MT-1303 in Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 2
Terminated NCT01708629 - Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects Phase 3
Completed NCT01230138 - Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis Phase 2
Withdrawn NCT00747032 - To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Suspended NCT01228656 - Effectiveness of Association Mometasone Furoate 0.1% and Salicylic Acid 5% Compared With Mometasone Furoate Phase 2
Completed NCT00540618 - A Phase II Study of MEDI-507, Administered by Injection to Adults With Psoriasis Phase 2