NCT01483924

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2011

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 20, 2015

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

1.8 years

First QC Date

November 30, 2011

Results QC Date

January 20, 2015

Last Update Submit

February 9, 2015

Conditions

Plaque Psoriasis

Keywords

Mild to Moderate Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Adverse Events

    The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.

    12 Weeks

Secondary Outcomes (8)

  • Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14

    12 hours

  • Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14

    12 hours

  • AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14

    12 hours

  • T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14

    12 hours

  • Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores

    Baseline to 12 Weeks

  • +3 more secondary outcomes

Study Arms (4)

10 mg Apo805K1, or placebo

EXPERIMENTAL
Drug: Apo805K1

30 mg Apo805K1, or placebo

EXPERIMENTAL
Drug: Apo805K1

60 mg Apo805K1, or placebo

EXPERIMENTAL
Drug: Apo805K1

100 mg Apo805K1, or placebo

EXPERIMENTAL
Drug: Apo805K1

Interventions

Apo805K1DRUG

Sequential parallel dose escalation.

10 mg Apo805K1, or placebo100 mg Apo805K1, or placebo30 mg Apo805K1, or placebo60 mg Apo805K1, or placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Axis Clinical Trials

Los Angeles, California, 90017, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Center for Clinical Studies

Houston, Texas, 77598, United States

Location

The University of Utah

Salt Lake City, Utah, 84132, United States

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K4L5, Canada

Location

Results Point of Contact

Title
Fernando Tricta, MD
Organization
ApoPharma Inc.
ftricta@apopharma.com
Phone: 416-401-7332

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

December 2, 2011

Study Start

November 1, 2011

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

February 20, 2015

Results First Posted

February 20, 2015

Record last verified: 2015-02

Locations

CA(1)US(6)