Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata

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Brief Title

Pilot Study to Evaluate the Efficacy of Ruxolitinib in Alopecia Areata

Official Title

An Open-Label Pilot Study to Evaluate the Efficacy of Ruxolitinib in Moderate to Severe Alopecia Areata

Brief Summary

      Alopecia areata (AA) is a common disease of the immune system, known as an "autoimmune"
      disease. In the disease, the immune system mistakenly destroys the hair follicle, causing
      hair to fall out. Despite many people having this disease, research into its cause and into
      new, better ways to treat AA has lagged far behind other similar diseases of the immune
      system. Currently, there are no Federal Drug Administration approved drugs for AA.

      Ruxolitinib (made by Incyte) is an intervention known to effectively treat a disease of the
      bone marrow, known as myelofibrosis. It is also being studied in the treatment of rheumatoid
      arthritis, another "autoimmune" disease, by fighting inflammation. There are some genetic and
      chemical similarities between those with myelofibrosis, active rheumatoid arthritis and AA,
      suggesting that treatment with ruxolitinib may be effective in AA. In mice specially designed
      for testing drugs for the treatment of human alopecia areata, this medication worked to
      prevent the disease AA from starting in mice that would have otherwise developed the disease.
      To test Ruxolitinib, we are going to treat 12 patients with moderate to severe AA for a
      minimum of 3 months up to 6 months. This is an "open-label" study, meaning that there will
      not be a placebo group; all patients enrolled in the study will receive the active
      medication. The effectiveness of the medication will be measured by changes in hair re-growth
      as determined by physical exam and photography, as well as by patient and physician scoring.
      Patients will be followed for another 3 months off of the drug to see if the effects of
      treatment last and if there is delayed response. The safety of the medication, ruxolitinib,
      in patients with alopecia areata will also be evaluated.

      Blood work will be collected before medication is started, during the treatment period, and
      after ruxolitinib is stopped, in order to monitor for adverse effects of the medication.
      Small scalp biopsies and peripheral blood will be taken at the beginning of the study before
      treatment and also after 12 and possibly 24 weeks. Optional biopsies may also be taken at
      additional time points based on clinical considerations. The chemical analysis of these skin
      samples and blood will help us to understand how the disease happens, how the treatment
      works, and may even guide us to better treatments in the future.
    

Detailed Description

      Alopecia areata (AA) is a common autoimmune disease resulting from immune destruction of the
      hair follicle and subsequent hair loss. Despite its high prevalence, research into the
      pathogenesis and the development of innovative therapies in AA has lagged far behind other
      autoimmune diseases. Currently, there are no FDA approved drugs for AA. Ruxolitinib (Incyte)
      is an intervention known to effectively treat myelofibrosis and also rheumatoid arthritis by
      modulating the inflammatory response of the interferon response pathway by inhibition of
      Jak1/Jak2. Rheumatoid arthritis shares several susceptibility genes in common with AA. All
      three diseases share the central role of the interferon-gamma response pathway, which is the
      rationale for selecting Ruxolitinib for evaluation in this clinical trial. Both systemic and
      topical Ruxolitinib have been shown to prevent the onset of AA in the C3H-HeJ animal model of
      AA, demonstrating preclinical proof-of-concept data in AA. To test the safety and efficacy of
      Ruxolitinib in patients with moderate to severe AA, we propose this open-label, single arm
      pilot study with a total of 12 patients, treated for a minimum of 3 months up to 6 months.
      Efficacy will be measured by changes in hair re-growth as determined by physical exam and
      photography, as well as by patient and physician global evaluation scores. Patients will be
      followed for another 3 months to evaluate durability of response following the treatment
      phase. Punch biopsies and peripheral blood will be obtained at baseline prior to treatment
      and then after 12 and possibly 24 weeks for immune monitoring and for molecular studies.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in SALT Score

Secondary Outcome

 Percentage of Regrowth

Condition

Alopecia Areata

Intervention

Ruxolitinib

Study Arms / Comparison Groups

 Ruxolitinib
Description:  A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

August 2013

Completion Date

April 2016

Primary Completion Date

April 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients between 18 to 75 years of age.

          -  Patients with a diagnosis of patch type alopecia areata.

          -  Patients will have >30% and <95% total scalp hair loss at baseline as measured using
             the SALT score. Two patients with current episodes of alopecia totalis/universalis may
             be included in this study.

          -  Duration of hair loss greater than 3 months.

          -  No evidence of regrowth present at baseline.

          -  Patients may be naïve to treatment or unresponsive to intralesional (IL) steroids or
             other treatments for alopecia areata.

        Exclusion Criteria:

          -  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.

          -  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.

          -  Patients with history or evidence of hematopoietic abnormality.

          -  Patients with <200K platelet count at baseline.

          -  Patients with history or evidence of renal or hepatic impairment.

          -  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 any medication considered a strong CYP3A4 inhibitor who is unable or
             unwilling to stop this medication for the duration of the study.

          -  Patients receiving treatment deemed to affect alopecia areata within 2 weeks to one
             month of baseline visit depending on the specific treatment.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Julian Mackay-Wiggan, MD, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01950780

Organization ID

AAAL7102


Responsible Party

Sponsor

Study Sponsor

Columbia University

Collaborators

 Alopecia Areata Initiative - Gates Foundation

Study Sponsor

Julian Mackay-Wiggan, MD, MS, Principal Investigator, Columbia University


Verification Date

April 2019