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

NCT04034134 | Completed Phase 2

• 1 other identifier: ZGJAK003
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• SALT score change

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

• Quality of Life (AASIS)

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

Other Outcomes (1)

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

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

Study Arms (3)

Jaktinib Hydrochloride Tablets 50mg bid

EXPERIMENTAL

Oral tablet for 24 weeks

Drug: Jaktinib Hydrochloride Tablets

Jaktinib Hydrochloride Tablets 150mg qd

EXPERIMENTAL

Oral tablet for 24 weeks

Drug: Jaktinib Hydrochloride Tablets

Jaktinib Hydrochloride Tablets 200mg qd

EXPERIMENTAL

Oral tablet for 24 weeks

Drug: Jaktinib Hydrochloride Tablets

Interventions

Jaktinib Hydrochloride Tablets DRUG

50 mg twice-daily (BID)

Jaktinib Hydrochloride Tablets 50mg bid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (2)

Chongqing Chinese Traditional Medicine Hospital

Chongqing, Chongqing Municipality, 400011, China

Location

The second xaingya hospital of central south university

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• qianjin Lu, MD

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 26, 2019
• Study Start: November 18, 2019
• Primary Completion: November 26, 2021
• Study Completion: November 26, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (2)