WBI-1001-201: Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis

Sponsor

Welichem Biotech Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00837551

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells through inhibition of T-cell activities including their infiltration processes, and it shows direct anti-inflammatory manifestation in the mouse edema model. This was a 28 day study (plus one follow-up week) on patients with Atopic Dermatitis, and 36 patients were treated randomly, BID with either 0.5%, 1.0% or placebo. Blood samples were taken weekly for PK analysis.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic	Drug: WBI-1001	Phase 1/Phase 2

Detailed Description

A double-blind, single-centered, vehicle-controlled, randomized Phase IIa study of WBI-1001 on patients with mild to moderate Atopic Dermatitis (AD). All body areas were treatable except face, scalp, groin and genital areas. Cream applied BID between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks. Blood draws for PK analysis were taken weekly at the study centre prior to the morning cream application. Patients returned to the study centre approximately one week later for a follow-up visit.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blinded, Vehicle-Controlled Phase IIa Study to Evaluate Topically Applied WBI-1001 Cream in Patients With Atopic Dermatitis.

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Placebo cream 0% cream 12 patients	Drug: WBI-1001 Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.
Active Comparator: 2. Cream 0.5% WBI-1001 cream 12 patients	Drug: WBI-1001 Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.
Active Comparator: 3. Cream 1.0% WBI-1001 cream 12 patients	Drug: WBI-1001 Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.

Arm

Intervention/Treatment

Placebo Comparator: 1 Placebo cream

0% cream 12 patients

Drug: WBI-1001

Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.

Active Comparator: 2. Cream

0.5% WBI-1001 cream 12 patients

Drug: WBI-1001

Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.

Active Comparator: 3. Cream

1.0% WBI-1001 cream 12 patients

Drug: WBI-1001

Doses of 0,0.5% and 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with one week follow-up.

Outcome Measures

Primary Outcome Measures

To evaluate skin lesion condition as a measure of safety and tolerability of WBI-1001 treated AD patients. [0, 7, 14, 21, 28 and 35 days]

Secondary Outcome Measures

Assess systemic exposure of WBI-1001 treated AD patients by measuring plasma PK. [0, 7, 14, 21 and 28 days]
Explore efficacy of topically applied WBI-1001 cream in patients with AD. [0, 7, 14, 21, 28 and 35 days.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

AD diagnosis (based on Hanifin's criteria) presenting a minimum of 1% and a maximum of 10% body surface area (BSA) excluding face, groin, scalp and genital areas.
Disease severity index (EASI) of less than 12, Investigator's Global Assessment (IGA) of 2-3 at Day 0.
In good general health and free of any condition that might impair evaluation of AD.
Women of child bearing potential (WOCBP) had to have a negative a negative serum human-beta chorionic gonadotropin pregnancy test before randomization.

WOCBP had to abstain from sex or they and their partners had to use adequate contraceptive precautions for the duration of the study.

Willing and able to comply with the protocol and attend all study visits.
Provide a written informed consent form prior to initiation of study procedures.

Exclusion Criteria:

Had spontaneously improving or rapidly deteriorating AD.
Had AD lesions on only hands and/or feet.
Had skin diseases other than AD.
Had active allergic contact dermatitis or other non-atopic forms of dermatitis.
Had other concomitant medical condition that could put the patient at risk during the study.
Had a history of neurological/psychiatric disorders that could interfere with the patient's participation.
Had systemic immunomodulatory therapies within 12 weeks prior to the baseline visit.
Had prolonged exposure to natural or artificial ultraviolet radiation within 4 weeks of baseline visit.
Had phototherapy (including laser), photo-chemotherapy or systemic AD therapy within 4 weeks prior to baseline visit.
Had topical AD therapies in the areas to be treated within 2 weeks prior to the baseline visit.
Had alcohol abuse in the last 2 years.
Had allergic history to any non-medical ingredients of the study cream.
Were treated with an investigational drug within 1 month of Day 0 or were currently participating in another trial.