Clinical trial NCT03222622: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mild to Moderate Psoriasis
Keywords: EGFR inhibitor, topical agent, psoriasis, phase 2
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2017-07-19
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of participants achieving a 50% improvement from baseline in psoriasis area and severity index (PASI 50) score at week 8
timeFrame: 8 weeks
Secondary outcomes:
measure: PASI 50 score at each visit through week 12 (except week 8)
timeFrame: Baseline to week 12 (except week 8)
measure: Percentage of participants achieving a 75% improvement from baseline in psoriasis area and severity index (PASI 75) score at each visit through week 12
timeFrame: Baseline to week 12
measure: Change PASI score at each visit from baseline through week 12
timeFrame: Baseline to week 12
measure: 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
timeFrame: Baseline to week 12
measure: Lesion severity
timeFrame: Baseline to week 12
Other outcomes:
measure: Safety in patients with mild to moderate psoriasis: Incidence and severity of Adverse Events, Physical Examinations, Vital signs, clinical laboratory assessments, ECG
timeFrame: Baseline to week 12
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to week 12
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Min Zheng, PHD
role: PRINCIPAL_INVESTIGATOR
References: