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

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ClinicalTrials.gov Identifier: NCT04034134
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Jaktinib Hydrochloride Tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅱ Study to Evaluate the Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Severe Alopecia Areata.
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Jaktinib Hydrochloride Tablets 50mg bid
Oral tablet for 24 weeks
Drug: Jaktinib Hydrochloride Tablets
50 mg twice-daily (BID)

Experimental: Jaktinib Hydrochloride Tablets 150mg qd
Oral tablet for 24 weeks
Drug: Jaktinib Hydrochloride Tablets
150 mg quaque die (QD)

Experimental: Jaktinib Hydrochloride Tablets 200mg qd
Oral tablet for 24 weeks
Drug: Jaktinib Hydrochloride Tablets
200 mg quaque die (QD)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034134


Contacts
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Contact: qianjin Lu, MD 13787097676 qianlu5860@gmail.com
Contact: siqi Fu, MD 18874139898 18874139898@163.com

Locations
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China, Chongqing
Chongqing Chinese Traditional Medicine Hospital Recruiting
Chongqing, Chongqing, China, 400011
Contact: Guofu Yan, Doctor    13983657860    yanguofucq@163.com   
China, Hunan
The second xaingya hospital of central south university Recruiting
Changsha, Hunan, China, 410011
Contact: qianjin Lu, MD    13787097676    qianlu5860@gmail.com   
Contact: siqi Fu, MD    18874139898    18874139898@163.com   
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
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Principal Investigator: qianjin Lu, MD Central South University
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT04034134    
Other Study ID Numbers: ZGJAK003
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical