Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306878
• Other study ID #: IM101-001
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2006
• Last updated: April 11, 2011
• Start date: August 1995
• Est. completion date: May 1997

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of BMS188667 (CTLA4Ig)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 1997
• Est. primary completion date: May 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures.

• Diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration.

• Psoriasis vulgaris total body surface area involvement between 10% and 49% (Overall Disease Severity Score [ODSS]of 4-7 inclusive).

• Failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate.

Exclusion Criteria:

• Treatment with: a) Retinoids within 2 years, b) cyclosporin A, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment.

• No clinical response to a prior adequate therapeutic trial of cyclosporin A

• Prolonged exposure to the sun within 4 weeks prior to the first dose.

• Guttate, erythrodermic, or pustular psoriasis.

• Spontaneously improving or rapidly deteriorating psoriasis vulgaris.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Abatacept

Locations

Country	Name	City	State
United States	Local Institution	Ann Arbor	Michigan
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	New York	New York
United States	Local Institution	Philadelphia	Pennsylvania
United States	Local Institution	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer		at Day 43
Secondary	Physician's globas Assessment		at Day 36
Secondary	Phage-neutralizing antibody titer		at Day 16 and Day 29
Secondary	Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected		at Day 43

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm