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Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

A 12-week Randomized, Double-blind, Placebo-controlled, Multicenter, Multiple Sequential Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT01483924•ApoPharma

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.

Detailed Description

A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1 B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days C) To evaluate the efficacy and pharmacodynamics of Apo805K1

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A clinical diagnosis of moderate to severe chronic plaque psoriasis for at least 6 months (before Baseline assessment) with current body surface area (BSA) involvement ≥10% and Psoriasis Area Severity Index (PASI) ≥10.
•Male and female subjects 18 to 65 years of age, inclusive.
•At least one psoriatic plaque ≥6 mm in diameter (in a location suitable for biopsy).
•Signed and witnessed written informed consent form obtained prior to the first study intervention, as well as the ability to adhere to study restrictions, appointments and evaluation schedule.

Exclusion Criteria

•Treatment of psoriasis with biologic agents within 90 days prior to Baseline assessment and during the study.
•Treatment with methotrexate, cyclosporine, retinoids, hydroxyurea or other systemic agents within 30 days prior to Baseline assessment and during the study.
•Phototherapy within 30 days prior to Baseline assessment and during the study.
•Psoriasis topical therapy within 14 days prior to Baseline assessment and during the study (exception: non-medicated emollients and tar shampoo will be allowed).
•History of liver disease or abnormal liver enzymes
•Serum creatinine ≥1.5 times the upper limit of normal for age and sex-matched controls.
•Previous treatment with Apo805K1or Thymodepressin or other immunosuppressant drugs.
•Evidence of skin conditions other than psoriasis (e.g., eczema) that could interfere with psoriasis assessments.
•History of chronic infection or malignancy

Locations (7)

Axis Clinical Trials

Los Angeles, California, United States

Axis Clinical Trials

Los Angeles, California, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

Center for Clinical Studies

Houston, Texas, United States

The University of Utah

Salt Lake City, Utah, United States

Innovaderm Research Inc.

Montreal, Quebec, Canada

Key Dates

Start Date

November 1, 2011

Primary Completion Date

August 1, 2013

Completion Date

October 1, 2013

Last Updated

February 20, 2015

Enrollment

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

Apo805K1

DRUG

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

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

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

NCT07250802

Plaque Psoriasis

View study

RECRUITINGPHASE2

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

NCT07449702

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: February 20, 2015Data 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.

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Study to Evaluate Apo805K1 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

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

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis