search
Back to results

Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

Primary Purpose

Mild to Moderate Psoriasis

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib hydrochloride cream
Placebo cream
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Psoriasis focused on measuring EGFR inhibitor, topical agent, psoriasis, phase 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosed plaque psoriasis for at least six months with multiple treatable areas (i.e. the lesion should not only on the face, scalp, genitals or skinfolds) which covers less than 10% of the total Body Surface Area (BSA), and affected area on the limb and/or trunk ≥ 1% BSA. The long diameter and thickness of target plaque psoriasis was ≥ 2cm and ≥2, respectively.
  • In good health condition, with no history of diseases of major organs and no abnormality found on physical examination and vital signs.
  • Men and women of childbearing potential must agree to use a contraceptive regimen agreed by the doctor during the trial. Female subjects that are on hormonal contraceptives must continue using the same hormonal contraceptive as that was used in the past 3 months, with the same route of administration and the same dose during the whole study.
  • Have signed a written informed consent before entering the study.

Exclusion Criteria:

  • Psoriasis guttata, psoriasis punctata, erythrodermic psoriasis, pustular psoriasis, psoriasis arthritis.
  • Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
  • Drug-induced psoriasis.
  • Present with or had historical interstitial lung disease.
  • In the opinion of the investigator, the subjects were not considered appropriate candidates.

Sites / Locations

  • The Second Affiliated hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

65 patients with mild to moderate psoriasis will be randomized to receive 1% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.

65 patients with mild to moderate psoriasis will be randomized to receive 2% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.

65 patients with mild to moderate psoriasis will be randomized to receive 4% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.

65 patients with mild to moderate psoriasis will be randomized to receive placebo cream (blank cream containing no icotinib hydrochloride), applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.

Outcomes

Primary Outcome Measures

Percentage of participants achieving a 50% improvement from baseline in psoriasis area and severity index (PASI 50) score at week 8
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.

Secondary Outcome Measures

PASI 50 score at each visit through week 12 (except week 8)
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.
Percentage of participants achieving a 75% improvement from baseline in psoriasis area and severity index (PASI 75) score at each visit through week 12
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline.
Change PASI score at each visit from baseline through week 12
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Percentage of participants achieving the physician global assessment (PGA) of psoriasis responses of clear (0) or almost clear (1) and ≥2 grade improvement at each visit through week 12
PGA of Psoriasis: score based on dermatologist's assessment of skin disease averaged over all lesions. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). Higher scores indicate greater severity of disease.
Lesion severity
Lesion severity includes the sum of 3 indications, e.g. Erythema, scaling, thickness of target psoriasis site on patients with mild to moderate psoriasis. Each indication is scored from 0 (not at all serious) to 4 (very serious).

Full Information

First Posted
July 14, 2017
Last Updated
November 9, 2018
Sponsor
Betta Pharmaceuticals Co., Ltd.
Collaborators
Tigermed Consulting Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03222622
Brief Title
Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis
Official Title
A Multicenter, Randomized, Double-blind, Four-Arm Parallel-Group, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
The efficacy failed to meet the primary efficacy endpoint
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.
Detailed Description
Icotinib Hydrochloride is an oral, small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for treating advanced non-small cell lung cancer (NSCLC) in China. Over-expressions of EGFR and its downstream signaling proteins are implicated in the pathogenesis of psoriasis and TKIs have been considered as potential antipsoriatic agents. Icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a multicenter , randomized, doubleblind, four-arm parallel-group, placebo-controlled phase II study to assess the efficacy and safety of icotinib hydrochloride cream (1.0%, 2.0%, 4.0%) in patients with mild to moderate psoriasis. Approximately 260 subjects will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Psoriasis
Keywords
EGFR inhibitor, topical agent, psoriasis, phase 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
65 patients with mild to moderate psoriasis will be randomized to receive 1% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
65 patients with mild to moderate psoriasis will be randomized to receive 2% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
65 patients with mild to moderate psoriasis will be randomized to receive 4% Icotinib hydrochloride cream, applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Arm Title
Cohort 4
Arm Type
Placebo Comparator
Arm Description
65 patients with mild to moderate psoriasis will be randomized to receive placebo cream (blank cream containing no icotinib hydrochloride), applied twice daily for 12 consecutive weeks. The drug will be applied topically to the psoriasis site.
Intervention Type
Drug
Intervention Name(s)
Icotinib hydrochloride cream
Other Intervention Name(s)
no other name
Intervention Description
Apply topically twice daily for 12 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Other Intervention Name(s)
no other name
Intervention Description
Apply topically twice daily for 12 consecutive weeks
Primary Outcome Measure Information:
Title
Percentage of participants achieving a 50% improvement from baseline in psoriasis area and severity index (PASI 50) score at week 8
Description
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
PASI 50 score at each visit through week 12 (except week 8)
Description
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50 represents the percentage (or number) of patients who have achieved a 50% or more reduction in their PASI score from baseline.
Time Frame
Baseline to week 12 (except week 8)
Title
Percentage of participants achieving a 75% improvement from baseline in psoriasis area and severity index (PASI 75) score at each visit through week 12
Description
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 represents the percentage (or number) of patients who have achieved a 75% or more reduction in their PASI score from baseline.
Time Frame
Baseline to week 12
Title
Change PASI score at each visit from baseline through week 12
Description
PASI: Combined assessment of lesion area and severity affected into single score. The body was divided into four sections [head (10% of a person's total skin); arms (20%); trunk (30%); legs (40%)]. For each section, the area of skin involved was scored from 0 (0%) to 6 (90-100%), and the severity of skin involved was estimated by clinical signs (erythema, induration, and desquamation) to score from 0 (none) to 4 (maximum). Final PASI = Sum of severity score for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Time Frame
Baseline to week 12
Title
Percentage of participants achieving the physician global assessment (PGA) of psoriasis responses of clear (0) or almost clear (1) and ≥2 grade improvement at each visit through week 12
Description
PGA of Psoriasis: score based on dermatologist's assessment of skin disease averaged over all lesions. Overall lesions were graded for induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). Higher scores indicate greater severity of disease.
Time Frame
Baseline to week 12
Title
Lesion severity
Description
Lesion severity includes the sum of 3 indications, e.g. Erythema, scaling, thickness of target psoriasis site on patients with mild to moderate psoriasis. Each indication is scored from 0 (not at all serious) to 4 (very serious).
Time Frame
Baseline to week 12
Other Pre-specified Outcome Measures:
Title
Safety in patients with mild to moderate psoriasis: Incidence and severity of Adverse Events, Physical Examinations, Vital signs, clinical laboratory assessments, ECG
Description
Incidence and severity of Adverse Events, Physical Examinations, Vital signs (temperature, Heart Rate, blood pressure and respiration rate), clinical laboratory assessments (serum chemistry, hematology, C-reactive protein, fecal and urinalysis), ECG, etc.
Time Frame
Baseline to week 12
Title
Dermatology Life Quality Index (DLQI)
Description
DLQI assessment includes 10 items, which encompass aspects such as symptoms and feelings, daily activities, leisure, work or school, personal relationships and side-effects of the treatment. Each item is scored from 0 (not at all relevant) to 1 (a little relevant), 2 (a lot relevant) and 3 (very much relevant). The scores of items 1-10 for change from baseline are summarized here.
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosed plaque psoriasis for at least six months with multiple treatable areas (i.e. the lesion should not only on the face, scalp, genitals or skinfolds) which covers less than 10% of the total Body Surface Area (BSA), and affected area on the limb and/or trunk ≥ 1% BSA. The long diameter and thickness of target plaque psoriasis was ≥ 2cm and ≥2, respectively. In good health condition, with no history of diseases of major organs and no abnormality found on physical examination and vital signs. Men and women of childbearing potential must agree to use a contraceptive regimen agreed by the doctor during the trial. Female subjects that are on hormonal contraceptives must continue using the same hormonal contraceptive as that was used in the past 3 months, with the same route of administration and the same dose during the whole study. Have signed a written informed consent before entering the study. Exclusion Criteria: Psoriasis guttata, psoriasis punctata, erythrodermic psoriasis, pustular psoriasis, psoriasis arthritis. Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. Drug-induced psoriasis. Present with or had historical interstitial lung disease. In the opinion of the investigator, the subjects were not considered appropriate candidates.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Zheng, PHD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

We'll reach out to this number within 24 hrs