NCT05676242

Brief Summary

To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

December 30, 2022

Last Update Submit

March 4, 2024

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

  • Number and percentage of subjects with treatment emergent adverse event (TEAE)

    Safety of the drug

    36 weeks after the first dose

  • Number and percentage of subjects with Serious Adverse Event (SAE)

    Safety of the drug

    36 weeks after the first dose

Secondary Outcomes (3)

  • The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline

    36 weeks after the first dose

  • The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline

    36 weeks after the first dose

  • The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline

    36 weeks after the first dose

Study Arms (3)

Jaktinib 100mg BID

EXPERIMENTAL

Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day

Drug: Jaktinib Hydrochloride Tablet

Jaktinib 75mg BID

EXPERIMENTAL

Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day

Drug: Jaktinib Hydrochloride Tablet

Placebo

PLACEBO COMPARATOR

Drug: Placebo Orally administered, twice a day

Drug: Jaktinib Hydrochloride Tablet

Interventions

Jaktinib Hydrochloride TabletDRUG

Orally administered, twice a day

Jaktinib 100mg BIDJaktinib 75mg BIDPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The investigator thinks that the subject can continue to benefit from participating in the extension trial;
  • Fully understand the extension trial and sign the informed consent form;
  • Complete the ZGJAK025 trial for 16 weeks and have good compliance;
  • It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;

You may not qualify if:

  • Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
  • The investigator thinks that the subject is not suitable for the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College

Nanjin, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jason Wu

    Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    STUDY CHAIR

Central Study Contacts

Cong Zhang

CONTACT

+86-0512-57018310zhangc@zelgen.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 9, 2023

Study Start

January 11, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)