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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00306878
• Collaborator: (none)
• Enrollment: 45
• Locations: 5
• Duration (Months): 21
• Patients Per Site: 9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: Abatacept	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
• Study Start Date: Aug 1, 1995
• Actual Primary Completion Date: May 1, 1997
• Actual Study Completion Date: May 1, 1997

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Physician's globas Assessment [at Day 36]

2. Phage-neutralizing antibody titer [at Day 16 and Day 29]

3. Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected [at Day 43]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Boston	Massachusetts	United States
2	Local Institution	Ann Arbor	Michigan	United States
3	Local Institution	New York	New York	United States
4	Local Institution	Philadelphia	Pennsylvania	United States
5	Local Institution	Pittsburgh	Pennsylvania	United States

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00306878
• Other Study ID Numbers: IM101-001
• First Posted: Mar 27, 2006
• Last Update Posted: Apr 13, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Psoriasis; Abatacept

Study Results

No Results Posted as of Apr 13, 2011