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

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034134
• Other study ID #: ZGJAK003
• Status: Completed
• Phase: Phase 2
• Start date: November 18, 2019
• Est. completion date: November 26, 2021

Study information

• Verified date: November 2022
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Drug:
• Jaktinib Hydrochloride Tablets
50 mg twice-daily (BID)
• Jaktinib Hydrochloride Tablets
150 mg quaque die (QD)
• Jaktinib Hydrochloride Tablets
200 mg quaque die (QD)

Locations

Country	Name	City	State
China	The second xaingya hospital of central south university	Changsha	Hunan
China	Chongqing Chinese Traditional Medicine Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety variables will be summarized using descriptive statistics based on adverse events collection	Patients with adverse events/all patients *100%	From randomization of the first subject until the last subject complete 6 months treatment
Primary	Effective rate	Effective rate = (cure + obvious effect + effective)/total cases *100%;	From randomization of the first subject until the last subject complete 6 months treatment
Secondary	SALT score change	Score and take photos (4 areas on the head), taking photos in the same position and light condition each time;	From randomization of the first subject until the last subject complete 6 months treatment
Secondary	Quality of Life (AASIS)	AASIS was used to score the quality of life of the subjects	From randomization of the first subject until the last subject complete 6 months treatment