Study of CRx-191 to Assess Activity in Plaque Psoriasis

NCT00557739 | Completed Phase 2

• 2 other identifiers: CRx-191-001Eudra CT #: 2006-005848-87
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

CRx-191; Plaque; Psoriasis; nortriptyline hydrochloride; mometasone furoate; psoriatic infiltrate

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the difference in reduction from baseline in psoriatic infiltrate at Day 12 between CRx-191 and vehicle.

  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.

  Day 12

Study Arms (6)

1

EXPERIMENTAL

CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)

Drug: mometasone furoate; Drug: nortriptyline HCl

2

EXPERIMENTAL

CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)

Drug: mometasone furoate; Drug: nortriptyline HCl

3

ACTIVE COMPARATOR

0.1% mometasone furoate

Drug: mometasone furoate

4

ACTIVE COMPARATOR

0.05% nortriptyline HCl

Drug: nortriptyline HCl

5

ACTIVE COMPARATOR

0.1% nortriptyline HCl

Drug: nortriptyline HCl

6

PLACEBO COMPARATOR

Vehicle (placebo)

Drug: Vehicle (placebo)

Interventions

mometasone furoate DRUG

Topical 0.1% mometasone furoate

1; 2; 3

nortriptyline HCl DRUG

Topical 0.05% or 0.1% nortriptyline HCl

1; 2; 4; 5

Vehicle (placebo) DRUG

Topical placebo

6

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Zalicus: lead
• Bioskin GmbH: collaborator

Study Sites (1)

bioskin GmbH

Berlin, Germany

Location

MeSH Terms

Conditions

Plaque, Amyloid; Psoriasis

Interventions

Mometasone Furoate; Nortriptyline

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Johannes Gassmueller, M.D.

  Bioskin GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 25, 2008

Record last verified: 2007-12

Locations

DE (1)