PsoriasisPhase 2134993NCT01098721
A Safety/Efficacy Study of a Non-steroid, Topical Cream Treatment of Psoriasis Over 12-weeks
A Phase 2 study testing WBI-1001 in people with Psoriasis, run by Welichem Biotech Inc..
Trial summary
Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- WBI-1001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to 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
- A clinical diagnosis of stable plaque psoriasis for at least 6 months representing a maximum of 10% of BSA with a minimum of 1% BSA excluding the face, groin ,scalp and genital regions and with a minimum of one target plaque that is at least 2 x 2 cm in size at Day 0.
- PGA of 2 to 4 at Day 0.
- In good general health and free of any disease state or physical condition that might impair the evaluation of plaque psoriasis.
- Women of child bearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotrophin (b-hCG) pregnancy test before randomization. WOBCP who are not abstinent from sex with male partners may be entered into the study if they are willing to continue to use adequate contraceptive precautions for the duration of the study. Male patients with female sexual partners who are able to become pregnant must ensure that an acceptable method of birth control is used while they are in the study. Women who are lactating will not be eligible for the study.
- Willing and able to comply with the protocol and likely to attend all study visits.
- Provide written, informed consent prior to the initiation of any study-related procedures.
Who cannot join
- Spontaneously improving or rapidly deteriorating plaque psoriasis.
- Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk.
- Pustular, erythrodermic or other non-plaque forms pf psoriasis.
- Guttate psoriasis as the dominant form of psoriasis.
- Other concomitant, serious illness or medical condition (eg., human immunodeficiency virus, renal insufficiency, clinically significant abnormal laboratory values) that could put the patient at risk during the study.
- History of neurological/psychiatric disorders, including psychotic disorders or dementia, or any other reason that would interfere with the patient's participation in the trial.
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- Systemic immunomodulatory therapy known to affect psoriasis and decreases immune cell populations (eg., alefacept) within 24 weeks of the baseline visit.
- Systemic immunomodulatory therapy known to affect psoriasis and that does not typically decrease immune cell populations (eg., etanercept) within 12 weeks prior to the baseline visit.
- Any phototherapy (including laser for the treatment of psoriasis), photo-chemotherapy,or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids or cyclosporine) within 4 weeks prior to the baseline visit.
- Prolonged exposure to artificial or natural sources of ultraviolet radiation within 4 weeks prior to the baseline visit or intention to have such exposure during the study, thought by the investigator likely to modify the patient's psoriasis.
- Topical anti-psoriatic therapy (including topical retinoids and vitamin D analogs) on the areas to be treated within 2 weeks prior to the baseline visit.
- Alcohol abuse during the last 2 years as defined by the consumption of >14 standard drinks of alcohol per week.
- Use of lithium within 2 weeks prior to the screening visit.
- Use of beta blockers (eg., propranolol) within 2 weeks prior to the screening visit unless on a stable dose for >3 months.
- Known or suspected hypersensitivity to any of the constituents of the investigational product.
- Treatment with an investigational drug within 1 month of Day 0 or current participation in another clinical trial.
About this study
Official title: A Double-blinded, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Topically Applied 1.0% WBI-1001 Cream for 12 Weeks, in the Treatment of Mild to Moderate Plaque Psoriasis.
Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. This study, in patients with mild to moderate plaque psoriasis, is designed to further determine the efficacy, safety and tolerability of the novel, topically applied, non-steroid, anti-inflammatory WBI-1001 cream over a period of 12 weeks.
Read the detailed description
A double-blinded, placebo-controlled study. Following screening, eligible patients will be randomized on Day 0 into one of two treatment groups in a 1:2 ratio:
Group 1: placebo (vehicle) cream, twice daily (BID). Group 2: 1.0% WBI-1001 cream, BID. Patients will be randomized to treat all treatable lesion areas except for the face, scalp, groin and genital areas, and will be instructed to apply the cream twice daily for 84 days, at the same time each day, once in the morning and once in the evening.
During the study patients will visit the study centre for assessment of efficacy, safety and tolerability at 0, 14, 28, 56 and 84 days after initiation, and patients will be phoned at Day 112 for a follow-up safety assessment.
Patients that withdraw from the study before Day 56 due to reasons other than adverse events will be replaced as necessary to ensure that there are at least 16 patients from the placebo and 32 from the active cream treated groups remaining in the study at Day 56.
- Conditions
- Psoriasis
- Being tested
- WBI-1001
- Keywords
- plaque psoriasis, skin diseases, anti-inflammatory, non-steroid, topical cream
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WBI-1001Drug
Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | A placebo cream applied topically twice daily (BID)by each of 20 patients, once in the morning and once in the evening for 12 weeks. Receives: Drug: WBI-1001 |
| Group 2 | Active comparator | A 1.0% WBI-1001 cream applied topically twice daily (BID) by each of 40 patients, once in the morning and once in the evening for 12 weeks. Receives: Drug: WBI-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001.
The primary indication of efficacy will be demonstrated by improvement in the Physician's Global Assessment (PGA) in patients treated with the active (1.0% WBI-1001) cream as compared with those treated with the placebo cream.
Measured: 84 days
Secondary outcomes (8)
Change in PASI score from baseline (Day 0) to Day 84 for patients in Group 1 compared with those in Group 2.
Change in the Psoriasis Area and Severity Index (PASI) score from the baseline (Day 0) at Day 84 in patients randomized to the placebo compared with those randomized to the 1.0% WBI-1001 cream treatment.
Measured: 84 days
Blood and urine analyses and vital signs assessments of patients from Day 0 to Day 84, and the follow-up at Day 112.
Comparative assessment of the laboratory analyses and vital signs of Group 1 and Group 2 patients from Day 0 to Day 84, and the follow-up at Day 112.
Measured: 84 days plus 112 day follow-up.
Change from baseline in BSA at Day 84 in patients randomized to placebo compared with those randomized to 1.0% WBI-1001 cream treatment.
Change in the BSA of involved skin (except for the face, scalp, groin and genital areas) from that at baseline (Day 0) to that at Day 84 when comparing patients in Group 1 with those in Group 2.
Measured: 84 days
Change from baseline (Day 0) in mean target lesion score at Day 84 in patients in Group 1 compared with those in Group 2.
Measured: 84 days
Change from baseline (Day 0)in target lesion induration at Day 84 in patients in Group 1 compared with those in Group 2.
Measured: 84 days
Change from baseline (Day 0) in target lesion scaling at Day 84 in patients in Group 1 compared with those in Group 2.
Measured: 84 days
Change from baseline (Day 0)in target lesion erythema at Day 84 in patients from Group 1 compared with those from Group 2.
Measured: 84 days
Type, frequency, severity and relationship of adverse events in patients from Group 1 compared with those from Group 2.
Measured: 84 days + follow-up at 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Welichem Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, MSc, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098721
- Sponsor's protocol ID
- WBI-1001-102
- Other IDs
- 134993
- Acronym
- 134993
- Status last verified
- Dec 2012
- First submitted
- 1 Apr 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Topically Applied 1.0% WBI-1001 Cream for 12 Weeks, in the Treatment of Mild to Moderate Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT01098721
- Acronym / sponsor ID
- 134993 / WBI-1001-102
- Conditions
- Psoriasis
- Keywords
- plaque psoriasis, skin diseases, anti-inflammatory, non-steroid, topical cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Welichem Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. This study, in patients with mild to moderate plaque psoriasis, is designed to further determine the efficacy, safety and tolerability of the novel, topically applied, non-steroid, anti-inflammatory WBI-1001 cream over a period of 12 weeks.
Detailed description
A double-blinded, placebo-controlled study. Following screening, eligible patients will be randomized on Day 0 into one of two treatment groups in a 1:2 ratio:
Group 1: placebo (vehicle) cream, twice daily (BID). Group 2: 1.0% WBI-1001 cream, BID. Patients will be randomized to treat all treatable lesion areas except for the face, scalp, groin and genital areas, and will be instructed to apply the cream twice daily for 84 days, at the same time each day, once in the morning and once in the evening.
During the study patients will visit the study centre for assessment of efficacy, safety and tolerability at 0, 14, 28, 56 and 84 days after initiation, and patients will be phoned at Day 112 for a follow-up safety assessment.
Patients that withdraw from the study before Day 56 due to reasons other than adverse events will be replaced as necessary to ensure that there are at least 16 patients from the placebo and 32 from the active cream treated groups remaining in the study at Day 56.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: WBI-1001A placebo cream applied topically twice daily (BID)by each of 20 patients, once in the morning and once in the evening for 12 weeks. |
| Group 2 | Active comparator | Drug: WBI-1001A 1.0% WBI-1001 cream applied topically twice daily (BID) by each of 40 patients, once in the morning and once in the evening for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A clinical diagnosis of stable plaque psoriasis for at least 6 months representing a maximum of 10% of BSA with a minimum of 1% BSA excluding the face, groin ,scalp and genital regions and with a minimum of one target plaque that is at least 2 x 2 cm in size at Day 0.
- PGA of 2 to 4 at Day 0.
- In good general health and free of any disease state or physical condition that might impair the evaluation of plaque psoriasis.
- Women of child bearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotrophin (b-hCG) pregnancy test before randomization. WOBCP who are not abstinent from sex with male partners may be entered into the study if they are willing to continue to use adequate contraceptive precautions for the duration of the study. Male patients with female sexual partners who are able to become pregnant must ensure that an acceptable method of birth control is used while they are in the study. Women who are lactating will not be eligible for the study.
- Willing and able to comply with the protocol and likely to attend all study visits.
Key exclusion criteria (16 listed)
- Spontaneously improving or rapidly deteriorating plaque psoriasis.
- Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk.
- Pustular, erythrodermic or other non-plaque forms pf psoriasis.
- Guttate psoriasis as the dominant form of psoriasis.
- Other concomitant, serious illness or medical condition (eg., human immunodeficiency virus, renal insufficiency, clinically significant abnormal laboratory values) that could put the patient at risk during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WBI-1001Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks. | Drug | Group 1, Group 2 |
Primary outcome
Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001.
Time frame: 84 days
The primary indication of efficacy will be demonstrated by improvement in the Physician's Global Assessment (PGA) in patients treated with the active (1.0% WBI-1001) cream as compared with those treated with the placebo cream.
8 secondary outcomes
Change in PASI score from baseline (Day 0) to Day 84 for patients in Group 1 compared with those in Group 2.
Time frame: 84 days
Blood and urine analyses and vital signs assessments of patients from Day 0 to Day 84, and the follow-up at Day 112.
Time frame: 84 days plus 112 day follow-up.
Change from baseline in BSA at Day 84 in patients randomized to placebo compared with those randomized to 1.0% WBI-1001 cream treatment.
Time frame: 84 days
Change from baseline (Day 0) in mean target lesion score at Day 84 in patients in Group 1 compared with those in Group 2.
Time frame: 84 days
Change from baseline (Day 0)in target lesion induration at Day 84 in patients in Group 1 compared with those in Group 2.
Time frame: 84 days
Change from baseline (Day 0) in target lesion scaling at Day 84 in patients in Group 1 compared with those in Group 2.
Time frame: 84 days
Change from baseline (Day 0)in target lesion erythema at Day 84 in patients from Group 1 compared with those from Group 2.
Time frame: 84 days
Type, frequency, severity and relationship of adverse events in patients from Group 1 compared with those from Group 2.
Time frame: 84 days + follow-up at 112 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD, MSc principal investigator
Innovaderm Research Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WBI-1001 in people with Psoriasis, run by Welichem Biotech Inc..
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 16 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 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001. (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2012.