Jaktinib Hydrochloride Cream For Atopic Dermatitis

NCT04435392 | Completed Phase 1

• 1 other identifier: ZGJAKT002
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

This study includes a dose escalation part and a dose extension part.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Jaktinib

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear

  A total PGA score of 0 or 1 or a decrease of ≥2 from baseline

  7 days after the last dose

Secondary Outcomes (1)

• Proportion of Participants With Response of Clear or Almost Clear From Baseline

  Treatment at 8,16 weeks

Study Arms (7)

Part 1: Cohort 1, 0.5% Jaktinib Bid

EXPERIMENTAL

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.

Drug: Jaktinib Hydrochloride Cream; Drug: Placebo

Part 1: Cohort 2,1.5% Jaktinib Bid

EXPERIMENTAL

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.

Drug: Jaktinib Hydrochloride Cream; Drug: Placebo

Part 1: Cohort 3, 2.5% Jaktinib Qd

EXPERIMENTAL

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.

Drug: Jaktinib Hydrochloride Cream; Drug: Placebo

Part 1: Cohort 4, 2.5% Jaktinib Bid

EXPERIMENTAL

Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.

Drug: Jaktinib Hydrochloride Cream; Drug: Placebo

Dose extension: Vehicle Control

PLACEBO COMPARATOR

the Vehicle Control cream will be applied topically twice daily

Drug: Placebo

Dose extension: low-dose group, X%

EXPERIMENTAL

X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily

Drug: Jaktinib Hydrochloride Cream

Dose extension: high-dose group, Y%

EXPERIMENTAL

Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily

Drug: Jaktinib Hydrochloride Cream

Interventions

Jaktinib Hydrochloride Cream DRUG

Subjects in each group were scheduled to give the drug for 8 weeks.

Also known as: Jaktinib

Dose extension: high-dose group, Y%; Dose extension: low-dose group, X%; Part 1: Cohort 1, 0.5% Jaktinib Bid; Part 1: Cohort 2,1.5% Jaktinib Bid; Part 1: Cohort 3, 2.5% Jaktinib Qd; Part 1: Cohort 4, 2.5% Jaktinib Bid

Placebo DRUG

Placebo

Dose extension: Vehicle Control; Part 1: Cohort 1, 0.5% Jaktinib Bid; Part 1: Cohort 2,1.5% Jaktinib Bid; Part 1: Cohort 3, 2.5% Jaktinib Qd; Part 1: Cohort 4, 2.5% Jaktinib Bid

Eligibility Criteria

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

You may qualify if:

• \~ 65 years old (including boundary value), gender is not limited;
• Have a clinical diagnosis of atopic dermatitis;
• Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline;
• The total area of atopic dermatitis is about 10%\~20% of the total area of the body surface at baseline.

You may not qualify if:

• Evidence of certain skin conditions/infections at baseline;
• Have certain laboratory abnormalities at baseline;
• Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception;
• Other conditions that the investigators considered inappropriate to participate in the trial.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Qianjin Lu, PhD

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: October 14, 2020
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

CN (1)