A Clinical Trial to Evaluate the Efficacy of Abatacept in Moderate to Severe Alopecia Areata

NCT01917058 | Withdrawn Phase 2 DMC

• 1 other identifier: AAAL0950
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if receiving sub-cutaneous injections of a medication called abatacept causes regrowth of hair in people with alopecia areata. Among patients with alopecia areata, patients with worse disease are unlikely to have satisfactory outcomes with current therapies. Our hypothesis is that Abatacept will be effective therapy in moderate to severe alopecia areata by blocking re-activation of a special type of immunecell call a memory T-Cell (CD8+NKG2D+)thereby blocking the inflammatory response underlying alopecia areata.

Conditions

Alopecia Areata

Keywords

Alopecia Areata; Abatacept

Outcome Measures

Primary Outcomes (1)

• SALT Score (Severity of Alopecia Tool)

  The primary efficacy endpoint of this intention-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 SALT score at week 24. This patient group and relatively strict definition for defining responders were chosen to minimize responses in the "vehicle" arm, in which 8% are expected to achieve this magnitude of hair regrowth spontaneously. To assess the durability of responses, patients who achieve 50% regrowth from baseline during the first 6 months, will continue to be followed for an additional 6 months off treatment or until it is determined that relapse has occurred.

  24 Weeks

Secondary Outcomes (2)

• Efficacy

  24 Weeks of Treatment and an additional 6 months off treatment or until determined that relapse has ocurred

• Safety

  24 Weeks of Treatment and an additional 6 months off treatment or until determined that relapse has ocurred

Study Arms (2)

abatacept

ACTIVE COMPARATOR

Drug: Abatacept

abatacept Subcutaneous vehicle

PLACEBO COMPARATOR

Drug: placebo

Interventions

Abatacept DRUG

This will be a randomized double blind placebo controlled study. Patients will be randomly assigned to abatacept or placebo in a 1:1 ratio based on a computer generated randomization list. The list will be generated prior to study initiation. Based on the randomization list, patients will be assigned to treatment vs. vehicle (provided by BMS) in the order in which they are enrolled. The assignment will be made by study personnel who are not involved in making clinical assessments or evaluations. The patient and the assessing physicians will remain blinded to the treatment assignment for the duration of the study. Patients will be treated with abatacept 125mg SC self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse.

Also known as: Brand Name: ORENCIA

abatacept

placebo DRUG

abatacept Subcutaneous vehicle

Eligibility Criteria

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

You may qualify if:

• Signed Written Informed Consent
• Must be between 18 and 75 years of age.
• Must have a diagnosis of moderate to severe AA - defined as the presence of equal to or more than 40% and equal to or less than 95% 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 AA.
• Must be willing to avoid live vaccines while on the study medication, and within 3 months of its discontinuation.
• Women of childbearing potential must use highly effective methods of birth control \[for up to 12 weeks after the last dose of investigational product\] to minimize the risk of pregnancy\].
• Women of childbearing potential must follow instructions for birth control for the entire duration of the study including a minimum of 90 days after dosing has been completed.
• Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
• Women must not be breastfeeding
• Sexually active fertile men must use highly effective birth control if their partners are women of childbearing potential.
• Men that are sexually active with women of childbearing potential must follow instructions for birth control for the entire duration of the study and a minimum of 90 days after dosing has been completed.

You may not qualify if:

• Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
• Women of childbearing potential using a prohibited contraceptive method.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or before administration of abatacept.
• Sexually active fertile men not using effective birth control if their partners are women of childbearing potential.
• Patients with alopecia totalis/universalis
• 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 with COPD
• Patients known to be HIV or hepatitis B or C positive.
• Patients with history or evidence of hematopoietic abnormality.
• Patients with history of immunosuppression or history of recurrent serious infections.
• Patients unwilling or unable to discontinue treatments known to affect hair regrowth in AA
• Patients taking TNF antagonists or other biological therapy such as anakinra.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center, Dept of Dermatology

New York, New York, 10032, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 6, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 24, 2014

Record last verified: 2014-07

Locations

US (1)