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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

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.

Key facts

Study ID

NCT01917058

Run by

Columbia University

People needed

0

Starts

2013-08-01

Expected to finish

2016-08-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• Patients known to be HIV or hepatitis B or C positive.
• Patients with evidence of infection or active/untreated skin cancer.
• Patients who have been treated with intralesional steroids, systemic steroids, anthralin, squaric acid, DPCP (diphenylcycloprophenone), protopic, minoxidil or other medication which in the opinion of the investigator may affect hair regrowth within one month of the baseline visit.
• Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
• Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
• Female subjects who have had a breast cancer screening that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded by additional clinical, laboratory, or other diagnostic evaluations.
• Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.
• Existing non-melanoma skin cell cancers should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug.
• Subjects who currently abuse drugs or alcohol.
• Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of human immunodeficiency virus (HIV) detected during screening.

Where it is running

• Columbia University Medical Center, Dept of Dermatology — New York, New York, United States

Full record on ClinicalTrials.gov

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