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

NCT03222622 | Terminated Phase 2

• 1 other identifier: BTP-16322
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Psoriasis

Keywords

EGFR inhibitor, topical agent, psoriasis, phase 2

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (5)

• PASI 50 score at each visit through week 12 (except week 8)

  Baseline to week 12 (except week 8)

• Percentage of participants achieving a 75% improvement from baseline in psoriasis area and severity index (PASI 75) score at each visit through week 12

  Baseline to week 12

• Change PASI score at each visit from baseline through week 12

  Baseline to week 12

• 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

  Baseline to week 12

• Lesion severity

  Baseline to week 12

Other Outcomes (2)

• Safety in patients with mild to moderate psoriasis: Incidence and severity of Adverse Events, Physical Examinations, Vital signs, clinical laboratory assessments, ECG

  Baseline to week 12

• Dermatology Life Quality Index (DLQI)

  Baseline to week 12

Study Arms (4)

Cohort 1

EXPERIMENTAL

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.

Drug: Icotinib hydrochloride cream

Cohort 2

EXPERIMENTAL

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.

Drug: Icotinib hydrochloride cream

Cohort 3

EXPERIMENTAL

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.

Drug: Icotinib hydrochloride cream

Cohort 4

PLACEBO COMPARATOR

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.

Drug: Placebo cream

Interventions

Icotinib hydrochloride cream DRUG

Apply topically twice daily for 12 consecutive weeks

Also known as: no other name

Cohort 1; Cohort 2; Cohort 3

Placebo cream DRUG

Apply topically twice daily for 12 consecutive weeks

Also known as: no other name

Cohort 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Min Zheng, PHD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 19, 2017
• Study Start: November 29, 2017
• Primary Completion: August 15, 2018
• Study Completion: October 26, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)