Study to Evaluate the Safety and Efficacy ofJaktinib Hydrochloride Tablets in Severe Alopecia Areata

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    111
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 9 June 2021
alopecia
areata alopecia

Summary

This was an open-label, Multi-center, randomized phase study. Patients with severe Alopecia Areata were randomized to receive 50mg bid, 150mg qd or 200 mg qd of oral Jaktinib Hydrochloride Tablets.

Details
Condition Alopecia Areata, Alopecia, Male Pattern Baldness, Hair Loss, areata alopecia
Treatment Jaktinib hydrochloride tablets
Clinical Study IdentifierNCT04034134
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on9 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 ageFemale patients must be satisfiedMenopause (defined as no menstruation for at least one year);Or have been surgically sterilizedOr have fertility, but must satisfyPregnancy tests conducted within 7 days before randomization must be negativeAnd agree to use appropriate contraceptive methods throughout the trial period, including at least one barrier methodAnd no breastfeedingMale 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 two weeks before randomizationPatients who received glucocorticoid topical therapy, anthracene ointment, minoxidil, SADBE/DPCP contact immunotherapy, photochemotherapy or cryotherapy
Before randomizationoral 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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