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Completed

NCT Number: NCT00306878

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

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)

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abatacept

Drug

Primary outcomes

  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

    Time frame: at Day 43

Secondary outcomes

  1. Physician's globas Assessment

    Time frame: at Day 36

  2. Phage-neutralizing antibody titer

    Time frame: at Day 16 and Day 29

  3. Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected

    Time frame: at Day 43

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
1995
Primary completion
1997
Study completion
1997
First posted
Mar 27, 2006
Registry last updated
Apr 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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