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A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Jaktinib Hydrochloride Tablet

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have fully understood the test and voluntarily signed the informed consent;
When signing the informed consent form, the age of male or female subjects must be ≥ 18 years old;
The onset time of atopic dermatitis was at least 1 year at the time of screening, and the subjects met the Hanifin and Rajka criteria for atopic dermatitis at the time of screening;
For women with reproductive ability and all male subjects, during the trial period and within 6 months after the discontinuation of the trial drug, they must maintain abstinence or contraception, including but not limited to physical and drug contraception.
The subjects were able to communicate well and agreed to follow the study and follow-up procedures.

Exclusion Criteria:

The investigator considers that any subjects are not suitable to participate in the trial.

Sites / Locations

139 People's Middle RoadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Jaktinib low dose

Jaktinib high dose

Placebo

Arm Description

Low dose

High dose

Placebo

Outcomes

Primary Outcome Measures

The efficacy in the treatment of moderate and severe atopic dermatitis

The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline

The efficacy in the treatment of moderate and severe atopic dermatitis

The proportion of subjects with a systemic Investigator's Global Assessment (IGA) score of 0 or 1 and a decrease of ≥ 2 points from baseline

Secondary Outcome Measures

The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Full Information

NCT ID

NCT05526222

First Posted

August 25, 2022

Last Updated

September 12, 2023

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05526222

Brief Title

A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Adult Patients With Moderate and Severe Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 14, 2022 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

438 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Jaktinib low dose

Arm Type

Experimental

Arm Description

Low dose

Arm Title

Jaktinib high dose

Arm Type

Experimental

Arm Description

High dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Jaktinib Hydrochloride Tablet

Intervention Description

Orally administered, twice a day

Primary Outcome Measure Information:

Title

The efficacy in the treatment of moderate and severe atopic dermatitis

Description

The proportion of subjects whose Eczema Area and Severity Index (EASI) total score decreased by ≥ 75% from baseline

Time Frame

16 weeks

Title

The efficacy in the treatment of moderate and severe atopic dermatitis

Description

The proportion of subjects with a systemic Investigator's Global Assessment (IGA) score of 0 or 1 and a decrease of ≥ 2 points from baseline

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis

Description

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Time Frame

up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have fully understood the test and voluntarily signed the informed consent; When signing the informed consent form, the age of male or female subjects must be ≥ 18 years old; The onset time of atopic dermatitis was at least 1 year at the time of screening, and the subjects met the Hanifin and Rajka criteria for atopic dermatitis at the time of screening; For women with reproductive ability and all male subjects, during the trial period and within 6 months after the discontinuation of the trial drug, they must maintain abstinence or contraception, including but not limited to physical and drug contraception. The subjects were able to communicate well and agreed to follow the study and follow-up procedures. Exclusion Criteria: The investigator considers that any subjects are not suitable to participate in the trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cong Zhang

Phone

+86-0512-57018308

zhangc@zelgen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason Wu

Organizational Affiliation

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Official's Role

Study Director

Facility Information:

Facility Name

139 People's Middle Road

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qianjin Lu

Phone

+8673185295999

Qianlu5860@gmail.com

First Name & Middle Initial & Last Name & Degree

Qianjin Lu, phD

First Name & Middle Initial & Last Name & Degree

Jianzhong Zhang, phD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis

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