Study to Evaluate the Efficacy and Safety of ZL-3101 in Subjects With Subacute Eczema

A Multi-center, Randomized, Double-blind, Parallel, Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Fugan Ointment (ZL-3101) in Subjects With Subacute Eczema

This is a double-blind, randomized, placebo-controlled multi-center phase IIA study to evaluate the clinical efficacy and safety of Fugan ointment versus placebo applied to involved skin of subjects with mild to moderate subacute eczema.

Study Overview

• Status: Completed
• Conditions: Eczema
• Intervention / Treatment: Drug: ZL-3101; Drug: Placebo

Detailed Description

In this study, patients will be recruited and randomized in a ratio of 2:2:1 into Fugan bid group (Fugan AM + Fugan PM), Fugan qd group (Fugan AM + Placebo PM), and placebo group (Placebo AM + Placebo PM). Randomization will be stratified by disease severity (mild IGA=2 vs. moderate IGA=3).

The patients will be given 3-week treatment and followed up for two weeks after the treatment.

Screening period is set as 1 week. Subjects will be given 3-week treatment and followed up for two weeks after the treatment.

Approximately 310 subjects will be randomized to achieve 250 evaluable subjects completing the study.

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Hospital of Traditional Chinese Medicine
  • Beijing, China
    • Dongzhimen Hospital, Beijing University of Chinese Medicine
  • Beijing, China
    • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
  • Nanjing, China
    • Jiangsu Province Hospital of Traditional Chinese Medicine
  • Shanghai, China
    • Shanghai Dermatology Hospital
  • Shanghai, China
    • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent; from outpatient clinic;

2. Subjects with a diagnosis of subacute eczema (Zhao 2001). Subacute eczema is often developed from improperly treated acute eczema or a few with presented subacute eczema from early on-set. Subacute eczema usually presents with papule, excoriations, crusting and pruritus. Occasionally patient will present with papulovesicle, blister and erosion. Patients also need to meet the requirement of:

   • Subjects must have body surface area (BSA) disease involvement between 3-10% (inclusive) as assessed by palm method;
   • IGA score of 2 or 3;
   • Skin lesions should be on the trunk or extremities, without palms/soles, face/scalp, and vulvar areas involved;

3. Based on TCM theory (Zheng 2002), patients with TCM "damp - heat" symptoms to be included. It is subject to TCM investigator's assessment, and symptoms could be (but not limited to):

   • Main symptoms: erythema, pruritus, papule with less exudation;
   • Secondary symptoms: Mild infiltration, excoriations, crusting, papulovesicle, blister, irritability, thirst, yellowish urine and dry stool;
   • Tongue and pulse analysis: red tongue with yellow or yellowish coating, slippery pulse model;
4. Subjects are general in good health; except for eczema, there are no other health conditions that possibly interfere with the study results;
5. A signed and dated written informed consent is obtained from the subject.

Exclusion Criteria:

1. The subject presents with or has the history of any systemic disorders or active skin diseases (e.g. psoriasis) that would in any way confound interpretation of the study results;
2. The subject has a current complication of overt bacterial, fungal or viral infection for which treatment with anti-infective are indicated;
3. Have the history of hepatic and kidney function insufficiency, hepatic dysfunction ALT or AST>1.5 ULN, kidney function BUN, Cr>1.5 ULN;
4. QT interval corrected according to Bazett's formula or QT interval corrected according to Fridericia's formula ≥450 msec; or QTc ≥480 msec in subjects with bundle branch block;
5. Have the history or examination verified by physical and screening of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, renal, hematological, neurological, abnormalities and psychology disorders which will interfere with the efficacy and/or safety of the individual subject;
6. History of allergy to any component of test medications to be used in the study;

7. The subject has been exposed to below therapy within the set timeframe:

   • Systemic administration of anti-histamine agents 1 week
   • Systemic administration of corticosteroid 4 weeks;
   • Topical corticosteroid agents administered in the diseased skin 1 week;
   • Systemic administration of immunosuppressive drugs 4 weeks;
   • Topical immunosuppressive drugs administered in the diseased skin 1 week;
   • Systemic administration of any TCM drugs 2 weeks;
   • Topical administration of any TCM drugs 1 week;
   • UV therapy 4 weeks

   The use of inhaled/intranasal steroids is permitted prior to and during the conduct of the study if already being used by the subject.

8. The subject has a past history of alcohol or drug abuse;
9. Pregnant women (as confirmed by a positive urine human chorionic gonadotrophin (HCG) test), women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control (birth control pill, patch, implant, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. An acceptable method of birth control must be used during the entire study in sexually active women of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered as a medically acceptable form of contraception;
10. The subject has received an investigational drug or participated in any other research trial within 30 days;
11. Other subjects that investigator deemed as unsuitable for the trial;
12. Subject's EASI score reaches 2 and above for lichenification and/or edema.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZL-3101(Fugan) bid group; Fugan AM + Fugan PM	Drug: ZL-3101; A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical; Other Names: Fugan ointment
Experimental: ZL-3101(Fugan) qd group; Fugan AM + Placebo PM	Drug: ZL-3101; A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical; Other Names: Fugan ointment; Drug: Placebo; A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical
Placebo Comparator: placebo group; Placebo AM + Placebo PM	Drug: Placebo; A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eczema Area and Severity Index (EASI) score changes from baseline to day 21	To evaluate efficacy of Fugan ointment applied to involved skin of subjects with mild to moderate subacute eczema	21 days

Collaborators and Investigators

• Sponsor: Zai Lab Pty. Ltd.
• Investigators: Principal Investigator: Bin Li, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): May 25, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: subacute
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: ZL-3101-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No