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Completed

NCT Number: NCT04034134

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chongqing Chinese Traditional Medicine Hospital, Chongqing, Chongqing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 two weeks 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.

Treatment and study plan

Jaktinib Hydrochloride Tablets

Drug

50 mg twice-daily (BID)

Primary outcomes

  1. Effective rate

    Time frame: From randomization of the first subject until the last subject complete 6 months treatment

    Effective rate = (cure + obvious effect + effective)/total cases *100%;

Secondary outcomes

  1. SALT score change

    Time frame: From randomization of the first subject until the last subject complete 6 months treatment

    Score and take photos (4 areas on the head), taking photos in the same position and light condition each time;

  2. Quality of Life (AASIS)

    Time frame: From randomization of the first subject until the last subject complete 6 months treatment

    AASIS was used to score the quality of life of the subjects

Other outcomes

  1. Safety variables will be summarized using descriptive statistics based on adverse events collection

    Time frame: From randomization of the first subject until the last subject complete 6 months treatment

    Patients with adverse events/all patients *100%

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Phase Ⅱ Study to Evaluate the Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Severe Alopecia Areata.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2019
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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