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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 1 Study of CC-90005 in Healthy Subjects and Subjects With Moderate to Severe Plaque-type Psoriasis

NCT02502188

Parapsoriasis Healthy Volunteers

TERMINATED PHASE1

Study to Investigate the Safety, Tolerability, Absorption, Distribution, Metabolism, and Elimination of RWJ-445380 Administered to Patients With Plaque Psoriasis

NCT00396422

Chronic Small Plaque Psoriasis

COMPLETED PHASE2

A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

NCT05120297

Psoriasis Vulgaris

COMPLETED PHASE3

A Study of BMS-582949 in Patients With Moderate to Severe Plaque Psoriasis

NCT00399906

Psoriasis

COMPLETED PHASE2

Efficacy 、Safety and PK of SHR-1314 in Patients With Moderate-to-Severe Plaque Psoriasis

NCT04839016

Moderate-to-Severe Plaque Psoriasis

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No