Jaktinib Dihydrochloride Monohydrate in Severe Alopecia Areata

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Brief Title

Jaktinib Dihydrochloride Monohydrate in Severe Alopecia Areata

Official Title

A PhaseⅡ Clinical Trial to Evaluating Safety and Efficacy of Jaktinib Dihydrochloride Monohydrate in the Treatment of Severe Alopecia Areata.

Brief Summary

      This was an open-label, randomized and single-arm phase Ⅱ study. Patients with severe
      Alopecia Areata were randomized via interactive voice/web response system 1:1 to receive
      either 150mg qd or 200 mg qd of oral Jaktinib Dihydrochloride Monohydrate
    

Detailed Description

      Clinical trial of Tofacitinib, Ruxolitinib, and Baricitinib have shown promising prospects
      for the treatment of alopecia areata (especially severe alopecia areata) with JAK
      inhibitors,Jaktinib Dihydrochloride Monohydrate is a potent inhibitor of JAK1 、JAK2 and
      JAK3.This was a phase Ⅱ, open-label, Multi-center,randomized study to Evaluating Safety and
      Efficacy of oral Jaktinib Dihydrochloride Monohydrate (150mg qd or 200 mg qd) for the
      treatment of severe Alopecia Areata.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

effective rate

Secondary Outcome

 SALT score change

Condition

Alopecia Areata

Intervention

Jaktinib hydrochloride tablets

Study Arms / Comparison Groups

 Jaktinib hydrochloride tablets 1
Description:  This is the dose group was given once a day. Jaktinib hydrochloride tablets 1 150mg qd dose group

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

104

Start Date

November 18, 2019

Completion Date

November 1, 2021

Primary Completion Date

September 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  18 years age or older ,male or female;

          -  Alopecia areata diagnosed clinically;

          -  Patients with alopecia accounting for 50% or more of the total scalp area and stable
             for at least 6 months or more;

          -  Patients can complete treatment for at least six months;

          -  Requirements for pregnant or lactating female and male and female of childbearing
             age;Female patients must be satisfied:Menopause (defined as no menstruation for at
             least one year);Or have been surgically sterilized;Or have fertility, but must
             satisfy:Pregnancy tests conducted within 7 days before randomization must be
             negative;And agree to use appropriate contraceptive methods throughout the trial
             period, including at least one barrier method;And no breastfeeding;Male patients must
             agree to use appropriate contraceptive measures throughout the trial, including at
             least one barrier method;

          -  Patients are voluntarily enrolled in the Study and can be treated and visited
             according to the requirements of the protocol after signing the Informed Consent Form;

        Exclusion Criteria:

          -  Alopecia caused by syphilitic alopecia, thyroid disease, trichotilomania, head moss,
             connective tissue disease, infection, zinc deficiency and iron deficiency;

          -  Patients with acute diffuse alopecia areata (ADTAFS)

          -  Patients with active tuberculosis

          -  The following diseases were combined within 6 months before randomization:thyroid
             diseases ,liver diseases, malnutrition, heart diseases, nervous system diseases,
             gastrointestinal disorders, tumors and psychiatric diseases

          -  HIV positive, active hepatitis B virus positive (HBsAg or HBeAg positive) and HCV-RNA
             positive at screening;

          -  Other patients with abnormal history or clinical manifestations that may affect
             participants participation in the study or may confuse the results of the study;

          -  Within one month before randomization,Patients who received glucocorticoid topical
             therapy, anthracene ointment, minoxidil, SADBE/DPCP contact immunotherapy,
             photochemotherapy or cryotherapy;

          -  Before randomization,oral or injected any medicines to treat hair loss (including the
             glucocorticoids was detected in injection, systemic corticosteroids, antihistamines,
             stephania drugs, glycyrrhizin, glycine, methionine compound tablet, compound
             glycyrrhizin glucoside) and other liquorice extract, ring spore element, anti TNF
             antibody, IFN - gamma, IL - 2 antibodies, for alopecia areata therapy of traditional
             Chinese medicine and other JAK inhibitor) and washout period less than seven half-life
             of patients;

          -  Participants in a clinical trial of any drug or medical device within 4 weeks prior to
             randomization;
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

qianjin Lu, MD, 13787097676, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04034134

Organization ID

ZGJAK003


Responsible Party

Sponsor

Study Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd


Study Sponsor

qianjin Lu, MD, Principal Investigator, Central South University


Verification Date

July 2019