Back to resultsNon-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
WBI-1001
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring non-steroid, anti-inflammatory, skin disease, topical cream, small molecule, atopic dermatitis, eczema
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of chronic atopic dermatitis (Hanifin's criteria) for greater than 6 months with a minimum of 5% and a maximum of 20% BSA.
- IGA scores of 2-4 at Day 0.
- WOCBP must have a negative serum beta-hCG pregnancy test before randomization, and they and their male partners must take pregnancy precautions for the duration of the study, as also must male patients.
- Willing to comply with Protocol and attend all visits.
- Provide written informed consent prior to entering study procedures.
- Patient has no latent or active tuberculosis infection according to medical history or current examination and tests.
Exclusion Criteria:
- Pregnancy or lactation.
- Spontaneously improving or rapidly deteriorating atopic dermatitis.
- Presence of atopic dermatitis on only hands and/or feet.
- Any skin disease other than atopic dermatitis that might interfere with clinical assessment or put patient at risk.
- Active allergic contact dermatitis or other non-atopic forms of atopic dermatitis.
- Other concommitant serious illness or medical condition, virus or renal insufficiency, or clinically significant abnormality that could put patient at risk during the study.
- History of neurological/psychiatric disorders including psychotic disorders, dementia or any other reason that would interfere with the patient's participation.
- Systemic immunomodulatory therapies for other conditions within 4 weeks prior to the baseline visit.
- Any phototherapy, photochemotherapy or systemic atopic dermatitis therapy within 2 weeks of the baseline visit.
- Prolonged exposure to natural or artificial sources of UV within 4 weeks prior to baseline visit or intention to have such exposure during the study.
- Topical atopic dermatitis therapies (including corticosteroids and calcineurins) in the areas to be treated within 2 weeks prior to baseline.
- Alcohol abuse in the last 2 years.
- Allergic history to any of the non-medical ingredients of the study cream.
- Treatment with an investigational drug within one month of Day 0 or current participation in another clinical trial.
Sites / Locations
- Guilford Dermatology Associates
- Department of Dermatology and Skin Sciences, UBC
- Windsor Clinical Research Inc.
- Innovaderm Research Inc.
- Centre de Recherche Dermatologique du Quebec
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
0%; vehicle cream
0.5% WBI-1001 cream
1.0% WBI-1001 cream
Outcomes
Primary Outcome Measures
Investigator's Global Assessment (IGA) score
To evaluate the efficacy of the 0.5% and 1.0% WBI-1001 creams in comparison with the vehicle placebo.
Secondary Outcome Measures
Eczema Area and Severity Index (EASI) score
Comparison over time with the placebo.
Scoring Atopic Dermatitis (SCORAD) Index.
Comparison over time with the placebo.
Clinical laboratory tests (haematology, urine) and vital signs.
Adverse events
BSA and pruritus.
Comparison over time with placebo.
Longterm change in IGA score of WBI-1001 cream groups.
Long term comparison, non-placebo, of the 0.5% and 1.0% cream treated groups of patients
Statistically significant improvement in the rate of "Treatment Success" with 0.5% and 1.0% WBI-1001 creams compared with placebo.
"Treatment Success" is defined as a patient who (1) achieves "clear" (IGA=0) or "almost clear" (IGA=1) on a five-point IGA scale or (2) has a minimum of 2-point improvement in IGA score over the baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01098734
Brief Title
Non-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream
Official Title
A 12-week Efficacy Evaluation of WBI-1001 Cream in Patients With Atopic Dermatitis: A Multi-centered, Double-blinded Study (6-week Placebo-controlled Phase Followed by a 6-week Non-placebo Controlled Phase).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Welichem Biotech Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a form of eczema).The purpose of this clinical trial is to further test the safety and efficacy of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with mild to moderate atopic dermatitis.
Detailed Description
A multi-centered, double-blinded Phase IIb study to evaluate the safety and efficacy of the non-steroid, anti-inflammatory WBI-1001 cream in the topical treatment of patients with mild to moderate atopic dermatitis, expressed as lesions up to 20% BSA. For the first 6 weeks patients will be randomized to one of three treatment groups simultaneously in a ratio of 1:1:1.
Group 1: vehicle cream (placebo), BID; Group 2: 0.5% WBI-1001 cream, BID; Group 3:1.0% WBI-1001 cream, BID. Patients randomized to treat all lesion areas.
After the first 6 weeks all patients will be treated, non-placebo controlled, with WBI-1001 cream. The Group 1 patients will enter a double-blinded phase for a further 6 weeks with half of them being treated BID with 0.5% and half with 1.0% WBI-1001 cream. Groups 2 and 3 will continue with their treatments unchanged for the remaining 6 weeks.
During the treatment period, patients will apply the cream (BID) from the kit that they have been provided, and they will visit the study centre at prescribed times for assessment of efficacy, safety and tolerability. After completion of the 12-week treatment period patients will have a 2-week follow-up visit.
Patients who withdraw from the study before Day 42 for reasons other than a treatment related AE will be replaced so that at least 40 patients per group will complete the placebo-controlled phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
non-steroid, anti-inflammatory, skin disease, topical cream, small molecule, atopic dermatitis, eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
0%; vehicle cream
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
0.5% WBI-1001 cream
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
1.0% WBI-1001 cream
Intervention Type
Drug
Intervention Name(s)
WBI-1001
Intervention Description
A 12-week study to assess the efficacy, safety and tolerability of topically applied WBI-1001 creams. First 6 weeks will be double-blinded, placebo-controlled and the following 6 weeks will be double-blinded, non-placebo- controlled. After 6 weeks patients in Groups 2 and 3 will continue double-blinded treatment for a further 6 weeks, but patients in Group 1 will enter a 6-week double-blinded phase with one of the two active creams (half treated with 0.5% and half with 1.0% WBI-1001 cream). All patients treated twice daily (BID).
Primary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) score
Description
To evaluate the efficacy of the 0.5% and 1.0% WBI-1001 creams in comparison with the vehicle placebo.
Time Frame
The change from baseline to 6 weeks.
Secondary Outcome Measure Information:
Title
Eczema Area and Severity Index (EASI) score
Description
Comparison over time with the placebo.
Time Frame
The change from baseline to 6 weeks.
Title
Scoring Atopic Dermatitis (SCORAD) Index.
Description
Comparison over time with the placebo.
Time Frame
Change from baseline to 6 weeks.
Title
Clinical laboratory tests (haematology, urine) and vital signs.
Time Frame
From baseline through 12 weeks+2 weeks follow-up
Title
Adverse events
Time Frame
From baseline through 12 weeks+2 weeks follow-up
Title
BSA and pruritus.
Description
Comparison over time with placebo.
Time Frame
From baseline through 6 weeks.
Title
Longterm change in IGA score of WBI-1001 cream groups.
Description
Long term comparison, non-placebo, of the 0.5% and 1.0% cream treated groups of patients
Time Frame
Change from baseline through 12 weeks
Title
Statistically significant improvement in the rate of "Treatment Success" with 0.5% and 1.0% WBI-1001 creams compared with placebo.
Description
"Treatment Success" is defined as a patient who (1) achieves "clear" (IGA=0) or "almost clear" (IGA=1) on a five-point IGA scale or (2) has a minimum of 2-point improvement in IGA score over the baseline.
Time Frame
First 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronic atopic dermatitis (Hanifin's criteria) for greater than 6 months with a minimum of 5% and a maximum of 20% BSA.
IGA scores of 2-4 at Day 0.
WOCBP must have a negative serum beta-hCG pregnancy test before randomization, and they and their male partners must take pregnancy precautions for the duration of the study, as also must male patients.
Willing to comply with Protocol and attend all visits.
Provide written informed consent prior to entering study procedures.
Patient has no latent or active tuberculosis infection according to medical history or current examination and tests.
Exclusion Criteria:
Pregnancy or lactation.
Spontaneously improving or rapidly deteriorating atopic dermatitis.
Presence of atopic dermatitis on only hands and/or feet.
Any skin disease other than atopic dermatitis that might interfere with clinical assessment or put patient at risk.
Active allergic contact dermatitis or other non-atopic forms of atopic dermatitis.
Other concommitant serious illness or medical condition, virus or renal insufficiency, or clinically significant abnormality that could put patient at risk during the study.
History of neurological/psychiatric disorders including psychotic disorders, dementia or any other reason that would interfere with the patient's participation.
Systemic immunomodulatory therapies for other conditions within 4 weeks prior to the baseline visit.
Any phototherapy, photochemotherapy or systemic atopic dermatitis therapy within 2 weeks of the baseline visit.
Prolonged exposure to natural or artificial sources of UV within 4 weeks prior to baseline visit or intention to have such exposure during the study.
Topical atopic dermatitis therapies (including corticosteroids and calcineurins) in the areas to be treated within 2 weeks prior to baseline.
Alcohol abuse in the last 2 years.
Allergic history to any of the non-medical ingredients of the study cream.
Treatment with an investigational drug within one month of Day 0 or current participation in another clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liren Tang, Ph.D
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Guilford Dermatology Associates
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Department of Dermatology and Skin Sciences, UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Windsor Clinical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 6A7
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Non-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream
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