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Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (AA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051761
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary:
This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and <65 years) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: Jaktinib Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Jaktinib in Adult Patients With Severe Alopecia Areata
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Jaktinib 50mg BID
Jaktinib administered orally. Placebo administered orally to maintain the blind.
Drug: Jaktinib
Administered orally.

Experimental: Jaktinib 75mg BID
Jaktinib administered orally. Placebo administered orally to maintain the blind.
Drug: Jaktinib
Administered orally.

Placebo Comparator: placebo
Placebo administered orally.
Drug: placebo
Administered orally.




Primary Outcome Measures :
  1. Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).


Secondary Outcome Measures :
  1. Percentage of Participants Achieving 50% Improvement of SALT (SALT50) [ Time Frame: Week 24 ]
    Percentage of participants achieving SALT50



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects voluntarily sign the informed consent form (ICF);
  • Age ≥ 18 years and <65 years, either male or female;
  • Clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years.
  • At least 50% scalp hair loss.
  • Willing to comply with the study visits and requirements of the study protocol.

Exclusion Criteria:

  • Subject has taken a JAK inhibitor prior to randomization;
  • Subjects who are unsuitable to the trial, as identified by the investigator.

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): NCT05051761


Contacts
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Contact: Qianjin Lu, PhD +86-0731-85295999 qianlu5860@gmail.com

Locations
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China, Jiangsu
No. 12, Jiangwangmiao Street, Xuanwu District Recruiting
Nanjing, Jiangsu, China, 210042
Contact: Qianjin Lu, PhD    +8673185295999    qianlu5860@gmail.com   
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
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Principal Investigator: Jianzhong Zhang, PhD Peking University People's Hospital
Principal Investigator: Qianjin Lu, PhD Hospital for skin diseases, Chinese Academy of Medical Sciences
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT05051761    
Other Study ID Numbers: ZGJAK018
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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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