Safety and Efficacy of Abatacept in Subjects With Chronic Urticaria Who Have Had an Inadequate Response to Anti-histamine Therapy

NCT00886795 | Completed Phase 1 Results DMC

• 1 other identifier: Tahoe-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).

Conditions

Urticaria

Keywords

hives; rash; pruritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Participants were monitored for adverse events (AEs) at each visit. Cumulative AEs were tracked including specific AE, severity, and relationship on source documentation. Special attention was given to infusion-related events and hypersensitivity reactions. Assessment of Complete Blood Count (CBC) and Metabolic profile were also tracked.

  baseline, 3 month and 6 months

Secondary Outcomes (1)

• Number of Participants With Clinically Detectable Improvement

  at each visit and at 3 months

Study Arms (1)

Abatacept

EXPERIMENTAL

4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.

Drug: abatacept (Orencia ®)

Interventions

abatacept (Orencia ®) DRUG

4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.

Also known as: orencia

Abatacept

Eligibility Criteria

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

You may qualify if:

• Chronic active urticaria defined as symptoms \> 50% of days or 3 days/week for more than 12 weeks
• Chronic therapy with stable doses of antihistamines for at least 4 weeks (patients may be taking more than one antihistamine or be taking combinations of antihistamines and leukotriene receptor antagonists) AND failure to respond to at least maximally approved dosages of 2 different antihistamine therapies
• One of the following 3 conditions:
• Previous or ongoing requirement for corticosteroids for symptom control OR
• Prior steroid treatment with steroid discontinuation due to unacceptable morbidity
• Previous or current use (without symptom control or with unacceptable morbidity: e.g., hypertension from cyclosporine, hemolysis from dapsone) of immunomodulatory treatment for urticaria (e.g., hydroxychloroquine, methotrexate, sulfasalazine, dapsone, cyclosporine, intravenous immunoglobulin (IVIg), mycophenolate, azathioprine, etc)
• High baseline score for pruritis (at least 2 on a 3 point scale)
• No underlying etiology clearly defined for urticaria
• Patients should exhibit evidence of underlying autoimmunity of at least one of the following:
• elevated erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), anti-nuclear antibody (ANA)
• extractable nuclear antigens
• Thyroid antibodies
• other autoantibodies (e.g., intrinsic factor, parietal cell, ovarian), \*elevated complement levels
• clinical characteristics suggestive of systemic autoimmune disease but without satisfying criteria for another diagnosis (e.g., arthralgias, myalgias, arthritis, low grade fever, significant fatigue associated with outbreaks)
• family history of autoimmune disease including thyroid autoimmunity

You may not qualify if:

• Current use of other immunosuppressive medications (cyclosporine, tacrolimus, sirolimus, IVIg, cyclophosphamide, mycophenolate mofetil, azathioprine). Any such medication will be discontinued for at least 4 weeks before study drug start.
• Concomitant treatment with corticosteroids (≤ 15 mg/d), hydroxychloroquine, methotrexate, and sulfasalazine will be permitted if doses are stable at least 8 weeks
• Treatment with an investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
• Receipt of a live vaccine within 4 weeks of randomization
• Prior treatment with Abatacept (Orencia®)
• Previous treatment with Rituximab (MabThera®/Rituxan®), unless 6 months after administration AND B cell reconstitution has occurred into normal range
• History of severe allergic or anaphylactic reactions to monoclonal antibodies or Fc fusion proteins
• Known history of Human Immunodeficiency Virus (HIV), Hepatitis B and/or Hepatitis C
• purified protein derivative (PPD) testing as part of screening that is positive\*
• HIV, Hepatitis B surface antigen or Core Antibody positive, or anti Hepatitis C Antibody positive detected with screening
• History of recurrent significant infection, active bacterial, viral, fungal, mycobacterial, or other infection excluding fungal infections of nail beds, or major infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 wks of screening
• Known immunodeficiency, hypogammaglobulinemia, etc.
• Systemic lupus erythematosus (meeting American College of Rheumatology (ACR)) criteria; patients with autoantibodies such as ANA will NOT be excluded)
• Lack of peripheral venous access
• Drug, alcohol, or chemical abuse within 6 months

Sponsors & Collaborators

• Johns Hopkins University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Johns Hopkins Arthritis Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Urticaria; Exanthema; Pruritus

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Limitations and Caveats

Open Label study. Small number of patients. Outcome measures for urticaria not standardized.

Results Point of Contact

• Title: Clifton O. Bingham III, M.D.
• Organization: Johns Hopkins University

cbingha2@jhmi.edu

410-550-0578

Study Officials

• Clifton O. Bingham, M.D.

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 25, 2016
• Results First Posted: January 25, 2016

Record last verified: 2015-12

Locations

US (1)