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

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

Study Overview

• Status: Completed
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Jaktinib Hydrochloride Tablets; Drug: Jaktinib Hydrochloride Tablets; Drug: Jaktinib Hydrochloride Tablets

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400011
      • Chongqing Chinese Traditional Medicine Hospital
  • Hunan
    • Changsha, Hunan, China, 410011
      • The second xaingya hospital of central south university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jaktinib Hydrochloride Tablets 50mg bid; Oral tablet for 24 weeks	Drug: Jaktinib Hydrochloride Tablets; 50 mg twice-daily (BID); Drug: Jaktinib Hydrochloride Tablets; 150 mg quaque die (QD); Drug: Jaktinib Hydrochloride Tablets; 200 mg quaque die (QD)
Experimental: Jaktinib Hydrochloride Tablets 150mg qd; Oral tablet for 24 weeks	Drug: Jaktinib Hydrochloride Tablets; 50 mg twice-daily (BID); Drug: Jaktinib Hydrochloride Tablets; 150 mg quaque die (QD); Drug: Jaktinib Hydrochloride Tablets; 200 mg quaque die (QD)
Experimental: Jaktinib Hydrochloride Tablets 200mg qd; Oral tablet for 24 weeks	Drug: Jaktinib Hydrochloride Tablets; 50 mg twice-daily (BID); Drug: Jaktinib Hydrochloride Tablets; 150 mg quaque die (QD); Drug: Jaktinib Hydrochloride Tablets; 200 mg quaque die (QD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: qianjin Lu, MD, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): November 26, 2021
• Study Completion (Actual): November 26, 2021

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: ZGJAK003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No