Plaque PsoriasisPhase 2NCT00557739
Study of CRx-191 to Assess Activity in Plaque Psoriasis
A Phase 2 study testing mometasone furoate and nortriptyline HCl in people with Plaque Psoriasis, run by Zalicus at 1 site in Germany.
Trial summary
CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- mometasone furoate and nortriptyline HCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Jan 2008
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must voluntarily give written informed consent
- Subject must be between 18 and 70 years of age
- Subject must have chronic plaque psoriasis and stable plaques in an area sufficient for six treatment fields
- The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
- Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen
Who cannot join
- Erythrodermic, guttate or pustular psoriasis
- Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- Mania
- Narrow angle glaucoma
- Hyperthyroidism by medical history, thyroid stimulating hormone (TSH) less than lower limit of normal (LLN), or receiving thyroid medication
- Intolerance to Lidocaine
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- Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 1.5x upper limit of normal (ULN))
- Inflammatory dermatoses except psoriasis; bacterial, viral and fungal skin infections; facial rosacea
- Active varicella, tuberculosis, syphilis or post-vaccine reaction
- Autoimmune disease other than plaque psoriasis (e.g. lupus erythematosis and psoriatic arthritis)
- Known allergic reactions or hypersensitivity to any of the components of the study preparations
- Allergy to adhesives on the hydrocolloid dressing used in this study
- UV therapy in the four weeks before the study
- History of malignancy (except for treated or excised basal cell carcinoma)
- Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- History of drug or alcohol abuse (as defined by the Investigator)
- Symptoms of a clinically significant illness in the four weeks before the study that may influence the outcome of the study
- Positive for HIV antibody
- Subjects who require systemically acting medications for the treatment of psoriasis which might counter or influence the study objectives such as: Methotrexate; Cyclosporine; Anti-TNFα therapies
- Subjects who require medications that inhibit the CYP450 2D6 pathway such as: Quinidine; Cimetidine; Type 1 antiarrhythmics; Phenothiazines; Selective serotonin reuptake inhibitors such as fluoxetine, paroxetine, and sertraline; Reserpine, other anticholinergic drugs, and sympathomimetic drugs
- Topical treatments for psoriasis (except for salicylic acid in vaseline) in the four weeks preceding and during the study (topical corticosteroids disallowed for eight weeks prior to the study)
- Systemic treatments in the two weeks preceding and during the study that may interact with any of the study drugs, such as: Glucocorticoids (po, im, iv); MAO inhibitors; Anti-depressants; Anti-seizure medications; Anti-psychotics; Antihistamines
- Treatments in the two weeks preceding and during the study that may aggravate psoriasis, such as: Anti-malarials; Beta-blockers
- Participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
- Female subject who is pregnant or lactating
- Significant UV exposure in the four weeks before the study
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
- Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment
- Subject is institutionalized because of legal or regulatory order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Activity of CRx-191 in Reducing the Psoriatic Infiltrate Band Thickness in Plaque Psoriasis
CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.
This clinical trial will assess the effectiveness of CRx-191 in reducing the psoriatic infiltrate band thickness as measured by transdermal ultrasound. All subjects will receive all treatments in separate test fields, with intra-individual comparison of the treatments.
- Conditions
- Plaque Psoriasis
- Being tested
- mometasone furoate, nortriptyline HCl, Vehicle (placebo)
- Keywords
- CRx-191, Plaque, Psoriasis, nortriptyline hydrochloride, mometasone furoate, psoriatic infiltrate
- Medical subject headings
- Plaque, Amyloid, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoateDrug
Topical 0.1% mometasone furoate
nortriptyline HClDrug
Topical 0.05% or 0.1% nortriptyline HCl
Vehicle (placebo)Drug
Topical placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl) Receives: Drug: mometasone furoate; Drug: nortriptyline HCl |
| 2 | Experimental | CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl) Receives: Drug: mometasone furoate; Drug: nortriptyline HCl |
| 3 | Active comparator | 0.1% mometasone furoate Receives: Drug: mometasone furoate |
| 4 | Active comparator | 0.05% nortriptyline HCl Receives: Drug: nortriptyline HCl |
| 5 | Active comparator | 0.1% nortriptyline HCl Receives: Drug: nortriptyline HCl |
| 6 | Placebo comparator | Vehicle (placebo) Receives: Drug: Vehicle (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the difference in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and vehicle.
Measured: Day 12
Secondary outcomes (1)
Differences in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and its components, mometasone furoate and nortriptyline HCI. Demonstrate tolerability and safety of CRx-191.
Measured: Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zalicus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Investigators
- Johannes Gassmueller, M.D., Principal investigator, Bioskin GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557739
- Sponsor's protocol ID
- CRx-191-001
- Other IDs
- Eudra CT #: 2006-005848-87
- Status last verified
- Dec 2007
- First submitted
- 12 Nov 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Activity of CRx-191 in Reducing the Psoriatic Infiltrate Band Thickness in Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00557739
- Acronym / sponsor ID
- CRx-191-001
- Conditions
- Plaque Psoriasis
- Keywords
- CRx-191, Plaque, Psoriasis, nortriptyline hydrochloride, mometasone furoate, psoriatic infiltrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Collaborators
- Bioskin GmbH
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Nov 2007 (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.
CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.
This clinical trial will assess the effectiveness of CRx-191 in reducing the psoriatic infiltrate band thickness as measured by transdermal ultrasound. All subjects will receive all treatments in separate test fields, with intra-individual comparison of the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mometasone furoate, Drug: nortriptyline HClCRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl) |
| 2 | Experimental | Drug: mometasone furoate, Drug: nortriptyline HClCRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl) |
| 3 | Active comparator | Drug: mometasone furoate0.1% mometasone furoate |
| 4 | Active comparator | Drug: nortriptyline HCl0.05% nortriptyline HCl |
| 5 | Active comparator | Drug: nortriptyline HCl0.1% nortriptyline HCl |
| 6 | Placebo comparator | Drug: Vehicle (placebo)Vehicle (placebo) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must voluntarily give written informed consent
- Subject must be between 18 and 70 years of age
- Subject must have chronic plaque psoriasis and stable plaques in an area sufficient for six treatment fields
- The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
- Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen
Key exclusion criteria (29 listed)
- Erythrodermic, guttate or pustular psoriasis
- Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- Mania
- Narrow angle glaucoma
- Hyperthyroidism by medical history, thyroid stimulating hormone (TSH) less than lower limit of normal (LLN), or receiving thyroid medication
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 |
|---|---|---|
| mometasone furoateTopical 0.1% mometasone furoate | Drug | 1, 2, 3 |
| nortriptyline HClTopical 0.05% or 0.1% nortriptyline HCl | Drug | 1, 2, 4, 5 |
| Vehicle (placebo)Topical placebo | Drug | 6 |
Primary outcome
The primary efficacy endpoint is the difference in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and vehicle.
Time frame: Day 12
1 secondary outcome
Differences in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and its components, mometasone furoate and nortriptyline HCI. Demonstrate tolerability and safety of CRx-191.
Time frame: Day 12
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 25 Sep 2008.
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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.
Johannes Gassmueller, M.D. principal investigator
Bioskin GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mometasone furoate and nortriptyline HCl in people with Plaque Psoriasis, run by Zalicus at 1 site in Germany.
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 5 inclusion and 29 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 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The primary efficacy endpoint is the difference in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and vehicle. (time frame: Day 12). 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 25 Sep 2008.