Abatacept Costimulatory Blockade in the Treatment of Alopecia Totalis/Universalis

NCT01314495 | Withdrawn Phase 2 DMC

• 1 other identifier: AAAI1530
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Will Abatacept reduce priming of the hair follicle specific T cells and thereby reduce hair follicle associated infiltration and improve hair growth. This is a double blind placebo controlled study to test the safety and efficacy of Abatacept in the treatment of 64 subjects diagnosed with alopecia totalis or alopecia universalis. Subjects will be randomized 1:1 to the placebo or treatment arm and will receive 6 months of treatment with the study medication or placebo, followed by a 6 month observational period.

Conditions

Alopecia Totalis/Universalis

Keywords

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• The study's primary endpoint will be the proportion of responders after 6 months of treatment, defined as 50% or greater hair re-growth from baseline as assessed by Severity of Alopecia Tool (SALT) score at week 24.

  The study's primary endpoint of this intent to treat trial will be the proportion of responders in the treated compared to the control group after 6 months of treatment, defined as 50% or greater hair re-growth from baseline as assessed by Severity of Alopecia Tool (SALT) score at week 24. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize responses in the 'vehicle' arm, in which fewer than 10% are expected to achieve this magnitude of hair re-growth spontaneously.

  24 weeks

Secondary Outcomes (1)

• Percent hair regrowth from baseline determined by SALT at weeks 4, 8, 12, 20, and 24 during treatment phase and at weeks 30, 36, 42 and 48 during the observational phase.

  24 weeks of treatment and 18 weeks observational phase

Study Arms (2)

Abatacept

ACTIVE COMPARATOR

Abatacept administered as a 30 minute intravenous infusion

Drug: Abatacept

Inactive infusion

PLACEBO COMPARATOR

Placebo will be administered as a 30 minute intravenous infusion.

Drug: Inactive infusion

Interventions

Abatacept DRUG

Abatacept will be administrated as a 30 minute intravenous infusion.

Abatacept

Inactive infusion DRUG

Placebo will be administered as a 30 minute intravenous infusion.

Inactive infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be between 18 and 75 years of age.
• Must have a diagnosis of alopecia totalis or alopecia universalis
• Must have \>75% total scalp hair loss at baseline as measured using the SALT score.
• Duration of hair loss must be between 3 to 12 months.
• There may be no evidence of regrowth present at baseline.
• Subjects may be naïve to treatment or unresponsive to intralesional (IL) steroids or other treatments for alopecia areata.
• Must be willing to avoid live vaccines while on the study medication, and within 3 months of its discontinuation.

You may not qualify if:

• Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis.
• Patients in whom the diagnosis of alopecia areata is in question.
• Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections.
• Patients who monitor their blood glucose levels using glucose dehydrogenase pyrrologuinolinequinone (GDH-PQQ) test strips. Blood glucose monitoring using other methods that do not react with maltose, such as the glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods are permitted.
• Patients taking TNF antagonists or other biological therapy such as anakinra.
• Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration.
• Women who are pregnant or nursing.
• Patients known to be HIV or hepatitis B or C positive.
• Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening.
• Patients with latent Mycobacterium tuberculosis infection as indicated by a positive Purified Protein Derivative \[PPD\] skin test. Subjects with a positive PPD skin test and documented completion of treatment per standard medical practice for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
• History of incompletely treated Mycobacterium tuberculosis infection as indicated by:
• Subject's medical records documenting incomplete treatment for Mycobacterium tuberculosis
• Subject's self-reported history of incomplete treatment for Mycobacterium tuberculosis
• Patients with evidence of infection or skin cancer in the treated areas.
• Patients with history or evidence of hematopoietic abnormality.

Sponsors & Collaborators

• Julian M. Mackay-Wiggan: lead

MeSH Terms

Conditions

Alopecia Areata

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Julian Mackay-Wiggan, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

• Angela Christiano, PhD

  Columbia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor of Dermatology

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11