Safety, Tolerability and Efficacy of ZEP-3Na (0.1% or 1%) Compared to Placebo in Subjects With Mild to Moderate Atopic Dermatitis

NCT04307862 | Unknown Phase 2

• 1 other identifier: ZEP-003-IL
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 10

Brief Summary

This is a phase II, double blind study with ZEP-3NA 0.1% or 1% vs. vehicle-control in subjects with mild to moderate Atopic Dermatitis. The IP (Investigational Product) will be administered topically twice daily for 4 weeks in the double blind phase. patients that will reach the primary endpoint will have the opportunity for additional to two weeks of open label treatment with ZEP-3Na 1%. The purpose of this study is to assess the safety, tolerability and efficacy of two concentrations of ZEP-3NA compared to vehicle-control.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• • Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment

  Lower score of IGA mean better outcome, higher score mean worse outcome

  Up to 4 weeks

Secondary Outcomes (16)

• • Proportion of subjects with IGA 0 to 1 (on a 5-point scale) and a reduction from baseline of ≥2 points during up to 4 weeks of double blind treatment and following additional up to 2 weeks of an open label extension with ZEP 3Na 1%, if applicable

  Up to 6 weeks

• • Proportion of subjects with EASI-50 (≥50% improvement from baseline) at end of treatment visit (EoT of the double blind part and EoT of the open label part, if applicable).

  Up to 6 weeks

• • Percent change in EASI-50 score from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).

  Up to 6 weeks

• • Percent change from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable) in pruritus NRS.

  Up to 6 weeks

• • Proportion of subjects with improvement (reduction) of pruritus NRS ≥3 points from baseline to EoT (EoT of the double blind part and EoT of the open label part, if applicable).

  Up to 6 weeks

Study Arms (3)

ZEP-3Na 0.1%

EXPERIMENTAL

The ZEP-3Na 0.1% cream will be applied topically twice daily

Drug: ZEP-3Na 0.1%

ZEP-3Na 1%

EXPERIMENTAL

The ZEP-3Na 1% cream will be applied topically twice daily

Drug: ZEP-3Na 1%

Vehicle Control

PLACEBO COMPARATOR

The Vehicle Control cream will be applied topically twice daily

Drug: Placebo Vehicle only

Interventions

ZEP-3Na 0.1% DRUG

The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase

ZEP-3Na 0.1%

ZEP-3Na 1% DRUG

The Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase, with optional 2 weeks of open label with ZEP-3Na 1%.

ZEP-3Na 1%

Placebo Vehicle only DRUG

he Investigational Product will be applied topically twice daily for up to 4 weeks in the double blind phase

Vehicle Control

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 5 to 75 years old, inclusive.
• Clinical diagnosis of Atopic Dermatitis (as defined by Hanifin and Rajka criteria).
• Atopic Dermatitis should be present for at least three months with stable disease for ≥ 1 month prior to screening.
• IGA score of 2 or 3 (mild or moderate) during screening and baseline.
• Women of child bearing potential must have a negative urine pregnancy test at screening and use an adequate contraceptive method throughout the study. Women of child bearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (such as: hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 24 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. Adequate method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm with spermicidal foam or jelly, or a condom), abstinence or vasectomy. Males with partners of childbearing potential should inform them of their participation in this clinical study and use an adequate contraceptive method throughout the study.
• Willing and able to comply with study instructions and commit to attending all visits.
• The patient/parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form prior to performing any study-related procedure. Adolescents age \>16 to 18 years old should be willing and able to sign Assent Form.

You may not qualify if:

• Unstable or actively infected atopic dermatitis.
• Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to study drug.
• Patients with Atopic Dermatitis affecting only the scalp will be excluded from the study. In addition, patients with the scalp representing ≥ 25% of the affected area will be excluded as well.
• Has received treatment two weeks prior to visit 2 (Day 1 of IP) with topical corticosteroids and/or topical immunosuppressive drugs or four weeks prior to visit 2 (Day 1 of IP) with systemic immunosuppressive drugs and/or corticosteroids or plans to receive treatment during the study timeframe with immunosuppressive drugs and/or corticosteroids (topical or systemic).
• Use of Crisaborole two weeks prior to visit 2 (Day 1 of IP).
• Prior use of Dupilumab.
• Subjects who are using any concomitant medications that, in the investigator's opinion, could affect the subject's atopic dermatitis (e.g Antihistamines). Subjects using such medications and have been stable on treatment for at least one month prior to visit 2 (Day 1 of IP) and no changes to these medications are planned during study, may be included in the study, at the investigator's discretion.
• Subject had UVA or UVB therapy two weeks prior to visit 2 (Day 1 of IP) or is due to have it during the study period.
• Any vaccination in the last 30 days prior to the screening visit. However, due to COVID-19 pandemic, only 1st vaccination for COVID is not allowed during only 21 days prior to visit 2 (Day 1 of IP) and during the study. The 2nd vaccination onwards is allowed at all times.
• Abnormal renal function (defined as serum creatinine \>1.5xULN).
• Abnormal liver function (defined as any transaminases \>2xULN).
• Clinically significant abnormalities as determined by the Investigator on the 12-lead ECG conducted at the screening visit (for adults only).
• Subject has active or history of malignancy, except non melanomatous skin cancer cured by excision. Subjects with past malignancy who had completed therapy and are free of the disease for at least 5 years may be included in the study, at the investigator's discretion.
• History of immunodeficiency syndrome (e.g. atypical rash morphology, severe bacterial, fungal or viral skin infections, etc).
• Subjects who are receiving any investigational drug or who participated in a clinical trial with an investigational product within the last 30 days or 5-half-lives of the investigational product, whichever is longer.

Sponsors & Collaborators

• Shulov Innovate for Science Ltd. 2012: lead

Study Sites (10)

Ha'Emek MC

Afula, Israel

TERMINATED

Barzilai MC

Ashkelon, Israel

TERMINATED

Rambam MC

Haifa, Israel

RECRUITING

Shaare Zedek MC

Jerusalem, Israel

RECRUITING

Clalit Health Services

Kfar Saba, Israel

RECRUITING

Prof. Shemer Clinic affiliated to Laniado MC

Netanya, Israel

RECRUITING

Clalit Health Services

Petah Tikva, Israel

WITHDRAWN

Clalit Health Services

Ramla, Israel

WITHDRAWN

Kaplan MC

Rehovot, Israel

RECRUITING

Tel-Aviv Sourasky MC

Tel Aviv, Israel

RECRUITING

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: March 13, 2020
• Study Start: December 29, 2019
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

IL (10)