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

Betta Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Mild to Moderate Psoriasis

Treatments: Drug: Icotinib hydrochloride cream; Drug: Placebo cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03222622

BTP-16322

Details and patient eligibility

About

This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

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.

Treatment:

Drug: Icotinib hydrochloride cream

Cohort 2

Experimental group

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.

Treatment:

Drug: Icotinib hydrochloride cream

Cohort 3

Experimental group

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.

Treatment:

Drug: Icotinib hydrochloride cream

Cohort 4

Placebo Comparator group

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.

Treatment:

Drug: Placebo cream