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Dermatitis, AtopicPhase 2NCT01098734

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

A Phase 2 study testing WBI-1001 in people with Dermatitis, Atopic, run by Welichem Biotech Inc. at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Dermatitis, Atopic
What is being tested?
WBI-1001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
5 sitesCanada
Study dates
Nov 2009to Nov 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Innovaderm Research Inc.

    Montreal, Quebec, H2K 4L5

  • Centre de Recherche Dermatologique du Quebec

    Québec, Quebec, G1V 4X7

  • Guilford Dermatology Associates

    Surrey, British Columbia, V3R 6A7

  • Department of Dermatology and Skin Sciences, UBC

    Vancouver, British Columbia, V5Z 4E8

  • Windsor Clinical Research Inc.

    Windsor, Ontario, N8W 6A7

Other trials in Canada

About this study

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).

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.

Read the 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.

Being tested
WBI-1001
Keywords
non-steroid, anti-inflammatory, skin disease, topical cream, small molecule, atopic dermatitis, eczema
Medical subject headings
Dermatitis, Atopic, Skin Diseases, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WBI-1001Drug

    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).

Study groups in NCT01098734
Study groupRoleWhat they receive
Group 1Placebo comparator0%; vehicle cream
Receives: Drug: WBI-1001
Group 2Active comparator0.5% WBI-1001 cream
Receives: Drug: WBI-1001
Group 3Active comparator1.0% WBI-1001 cream
Receives: Drug: WBI-1001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: The change from baseline to 6 weeks.

Secondary outcomes (7)

  1. Eczema Area and Severity Index (EASI) score

    Comparison over time with the placebo.

    Measured: The change from baseline to 6 weeks.

  2. Scoring Atopic Dermatitis (SCORAD) Index.

    Comparison over time with the placebo.

    Measured: Change from baseline to 6 weeks.

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

    Measured: From baseline through 12 weeks+2 weeks follow-up

  4. Adverse events

    Measured: From baseline through 12 weeks+2 weeks follow-up

  5. BSA and pruritus.

    Comparison over time with placebo.

    Measured: From baseline through 6 weeks.

  6. 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

    Measured: Change from baseline through 12 weeks

  7. 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.

    Measured: First 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionOct 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098734
Sponsor's protocol ID
WBI-1001-202 : # 133148
Other IDs
# 133148
Status last verified
Jun 2011
First submitted
1 Apr 2010
Last updated
13 Jun 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing WBI-1001 in people with Dermatitis, Atopic, run by Welichem Biotech Inc. at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator's Global Assessment (IGA) score (time frame: The change from baseline to 6 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.

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