Non-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream

This study has been completed.
Sponsor:
Information provided by:
Welichem Biotech Inc.
ClinicalTrials.gov Identifier:
NCT01098734
First received: April 1, 2010
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: WBI-1001
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Welichem Biotech Inc.:

Primary Outcome Measures:
  • Investigator's Global Assessment (IGA) score [ Time Frame: The change from baseline to 6 weeks. ] [ Designated as safety issue: No ]
    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 [ Time Frame: The change from baseline to 6 weeks. ] [ Designated as safety issue: No ]
    Comparison over time with the placebo.

  • Scoring Atopic Dermatitis (SCORAD) Index. [ Time Frame: Change from baseline to 6 weeks. ] [ Designated as safety issue: No ]
    Comparison over time with the placebo.

  • Clinical laboratory tests (haematology, urine) and vital signs. [ Time Frame: From baseline through 12 weeks+2 weeks follow-up ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: From baseline through 12 weeks+2 weeks follow-up ] [ Designated as safety issue: Yes ]
  • BSA and pruritus. [ Time Frame: From baseline through 6 weeks. ] [ Designated as safety issue: No ]
    Comparison over time with placebo.

  • Longterm change in IGA score of WBI-1001 cream groups. [ Time Frame: Change from baseline through 12 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: First 6 weeks ] [ Designated as safety issue: No ]
    "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.


Enrollment: 148
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1
0%; vehicle cream
Drug: WBI-1001
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).
Active Comparator: Group 2
0.5% WBI-1001 cream
Drug: WBI-1001
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).
Active Comparator: Group 3
1.0% WBI-1001 cream
Drug: WBI-1001
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098734

Locations
Canada, British Columbia
Guilford Dermatology Associates
Surrey, British Columbia, Canada, V3R 6A7
Department of Dermatology and Skin Sciences, UBC
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Ontario
Windsor Clinical Research Inc.
Windsor, Ontario, Canada, N8W 6A7
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Centre de Recherche Dermatologique du Quebec
Quebec City, Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Welichem Biotech Inc.
Investigators
Study Director: Liren Tang, Ph.D Sponsor GmbH
  More Information

No publications provided

Responsible Party: R. Bissonnette, MD, MSc, FRCPC, Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT01098734     History of Changes
Other Study ID Numbers: WBI-1001-202 : # 133148, # 133148
Study First Received: April 1, 2010
Last Updated: June 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by Welichem Biotech Inc.:
non-steroid
anti-inflammatory
skin disease
topical cream
small molecule
atopic dermatitis
eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014