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COMPLETEDPHASE2

Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis

Open-Label, Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC10004 in Subjects With Severe Plaque Type Psoriasis

NCT00604682•Amgen

View on ClinicalTrials.gov

Summary

Open label study for patients with severe plaque type psoriasis. This study is looking to evaluate the pharmacodynamic effect of CC10004 when taken for 29 days in reducing the epidermal thickness in subjects with severe placque type psoriasis.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must understand and voluntarily sign an informed consent form
•Must be age \> or = to 18 years to 65 years at the time of singing the informed consent form.
•Must be able to adhere to the study visit schedule and other protocol requirements
•Must have a history of severe plaque type psoriasis for at least 6 months, and at least a 15% affected total body surface area (BSA)
•Must meet the following clinical laboratory criteria:
•White Blood Cell Count \> or = to 3000/cu mm and \< 20,000/cu mm
•Platelet count \> or = to 100,000/microliters
•Serum creatinine \< or = to 1.5 mg/dl
•Total bilirubin \< or = to 2.0 mg/dl
•AST (SGOT) and ALT (SGPT) \< or = to 1.5 X ULN
+3 more criteria

Exclusion Criteria

•Any serious medical condition, laboratory abnormality , or psychiatric illness that would prevent the subject from signing the informed consent form
•Pregnant or lactating females
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
•Current erythrodermic, guttate, or pustular psoriasis
•Use of medication that is metabolized by the CYP3A4 or CYP2A6 pathways within the 14 days of study medication initiation and/or required use of such medication during study treatment.
•Drinking or ingesting grapefruits, grapefruit juice or grapefruit containing products within 14 days of study medication initiation
•Use of topical therapy ( topical steroids, topical vitamin A or D analog preparations, tacrolimus, pimecrolimus, or anthralin) within 14 days of study medications initiation (Exception: Non-medicated emollients and tar shampoo will be allowed)
•Use of systemic therapy for psoriasis
•Use or phototherapy within 28 days of study medication initiation
•Use Humira or Remicade within 3 months of study medication initiation
+12 more criteria

Locations (3)

University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, United States

NYU School of Medicine

New York, New York, United States

Mt Sinai School of Medicine

New York, New York, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

October 1, 2005

Completion Date

December 1, 2005

Last Updated

April 24, 2020

Enrollment

ACTUAL participants

Conditions

Psoriasis

Interventions

CC10004

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments