Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00710580
  4. Details
NCT00710580 Clinical Trial

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

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:
A Phase 3, Multicenter, 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 NCT00710580
Other study ID # M10-315
Secondary ID
Status Completed
Phase Phase 3
First received July 2, 2008
Last updated January 10, 2013
Start date July 2008
Est. completion date April 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 350
Est. completion date April 2009
Est. primary completion date April 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

  • Moderate to Severe Plaque Psoriasis
  • Psoriasis

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# 15201 Alpharetta Georgia
United States Site Reference ID/Investigator# 10762 Atlanta Georgia
United States Site Reference ID/Investigator# 9985 Bakersfield California
United States Site Reference ID/Investigator# 9786 Berlin New Jersey
United States Site Reference ID/Investigator# 10605 Birmingham Alabama
United States Site Reference ID/Investigator# 9984 Birmingham Alabama
United States Site Reference ID/Investigator# 9981 Dallas Texas
United States Site Reference ID/Investigator# 10504 Dayton Ohio
United States Site Reference ID/Investigator# 9788 Fort Gratiot Michigan
United States Site Reference ID/Investigator# 10541 Fridley Minnesota
United States Site Reference ID/Investigator# 10604 Grand Blanc Michigan
United States Site Reference ID/Investigator# 9902 Hickory North Carolina
United States Site Reference ID/Investigator# 10661 Irvine California
United States Site Reference ID/Investigator# 10503 Jacksonville Florida
United States Site Reference ID/Investigator# 10643 Knoxville Tennessee
United States Site Reference ID/Investigator# 10502 Little Rock Arkansas
United States Site Reference ID/Investigator# 14701 Los Angeles California
United States Site Reference ID/Investigator# 10265 Louisville Kentucky
United States Site Reference ID/Investigator# 10666 Maywood Illinois
United States Site Reference ID/Investigator# 10266 Miami Florida
United States Site Reference ID/Investigator# 9901 Miami Florida
United States Site Reference ID/Investigator# 10321 Milwaukee Wisconsin
United States Site Reference ID/Investigator# 10263 New Haven Connecticut
United States Site Reference ID/Investigator# 10241 New York New York
United States Site Reference ID/Investigator# 10262 Newnan Georgia
United States Site Reference ID/Investigator# 10606 Omaha Nebraska
United States Site Reference ID/Investigator# 10644 Omaha Nebraska
United States Site Reference ID/Investigator# 15750 Owensboro Kentucky
United States Site Reference ID/Investigator# 9790 Owensboro Kentucky
United States Site Reference ID/Investigator# 15142 Plainfield Indiana
United States Site Reference ID/Investigator# 9787 Rochester New York
United States Site Reference ID/Investigator# 10264 San Antonio Texas
United States Site Reference ID/Investigator# 9785 San Diego California
United States Site Reference ID/Investigator# 10662 Santa Monica California
United States Site Reference ID/Investigator# 10001 Scottsdale Arizona
United States Site Reference ID/Investigator# 10182 Seattle Washington
United States Site Reference ID/Investigator# 9789 Snellville Georgia
United States Site Reference ID/Investigator# 10641 St. Louis Missouri
United States Site Reference ID/Investigator# 10642 Vallejo California
United States Site Reference ID/Investigator# 9982 Webster Texas
United States Site Reference ID/Investigator# 10501 West Palm Beach Florida
United States Site Reference ID/Investigator# 10581 Wilmington North Carolina

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
  Status Clinical Trial Phase
Completed NCT05020249 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Korean Study Participants With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT01202565 - Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice N/A
Recruiting NCT05258331 - Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Psoriasis Phase 1
Withdrawn NCT03146247 - Analysis of the Pathogenesis of Itch in Response to Apremilast Therapy in Psoriasis Patients Phase 4
Recruiting NCT04367441 - Randomized, Double Blinded, Placebo Controlled, Single Dose Escalation Study of 608 in Healthy Subjects Phase 1
Completed NCT01644396 - An Open-Label, Prospective Study to Assess the Safety and Effectiveness of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in the Russian Federation Phase 4
Completed NCT01622348 - Trial of IMO-3100 in Patients With Moderate to Severe Plaque Psoriasis Phase 2
Recruiting NCT04566666 - To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis Phase 2
Active, not recruiting NCT05155098 - 2 Years Prospective Study to Collect Real-life Data on the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
Recruiting NCT06425549 - A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis Phase 3
Completed NCT01555606 - An Observational Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis Phase 4
Completed NCT02713295 - A Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece
Completed NCT05342428 - Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis Phase 1
Completed NCT04967508 - A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis Phase 3
Recruiting NCT06109818 - Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT01077232 - Documentation of Humira in Psoriasis Patients in Routine Clinical Practice
Completed NCT03412747 - A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis Phase 3
Withdrawn NCT04614298 - A Phase 4 Study of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis Phase 4
Completed NCT02982005 - A Study of KHK4827 (Brodalumab) in Subjects With Moderate to Severe Psoriasis in Korea Phase 3
Completed NCT00626002 - Open Label Continuation Study in Moderate to Severe Psoriasis Phase 3