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

NCT01098734 | Completed Phase 2 DMC

• 2 other identifiers: WBI-1001-202 : # 133148# 133148
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 5

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.

Conditions

Dermatitis, Atopic

Keywords

non-steroid; anti-inflammatory; skin disease; topical cream; small molecule; atopic dermatitis; eczema

Outcome Measures

Primary Outcomes (1)

• 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.

  The change from baseline to 6 weeks.

Secondary Outcomes (7)

• Eczema Area and Severity Index (EASI) score

  The change from baseline to 6 weeks.

• Scoring Atopic Dermatitis (SCORAD) Index.

  Change from baseline to 6 weeks.

• Clinical laboratory tests (haematology, urine) and vital signs.

  From baseline through 12 weeks+2 weeks follow-up

• Adverse events

  From baseline through 12 weeks+2 weeks follow-up

• BSA and pruritus.

  From baseline through 6 weeks.

Study Arms (3)

Group 1

PLACEBO COMPARATOR

0%; vehicle cream

Drug: WBI-1001

Group 2

ACTIVE COMPARATOR

0.5% WBI-1001 cream

Drug: WBI-1001

Group 3

ACTIVE COMPARATOR

1.0% WBI-1001 cream

Drug: WBI-1001

Interventions

WBI-1001 DRUG

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).

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Welichem Biotech Inc.: lead

Study Sites (5)

Guilford Dermatology Associates

Surrey, British Columbia, V3R 6A7, Canada

Location

Department of Dermatology and Skin Sciences, UBC

Vancouver, British Columbia, V5Z 4E8, Canada

Location

Windsor Clinical Research Inc.

Windsor, Ontario, N8W 6A7, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Centre de Recherche Dermatologique du Quebec

Québec, Quebec, G1V 4X7, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Skin Diseases; Eczema

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Liren Tang, Ph.D

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 5, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 13, 2011

Record last verified: 2011-06

Locations

CA (5)