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

Last updated: September 10, 2023
Sponsor: Shulov Innovate for Science Ltd. 2012
Overall Status: Active - Recruiting

Phase

2

Condition

Eczema (Atopic Dermatitis)

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Treatment

ZEP-3Na 1%

ZEP-3Na 0.1%

Placebo Vehicle only

Clinical Study ID

NCT04307862
ZEP-003-IL
  • Ages 5-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female 5 to 75 years old, inclusive.
  2. Clinical diagnosis of Atopic Dermatitis (as defined by Hanifin and Rajka criteria).
  3. Atopic Dermatitis should be present for at least three months with stable disease for ≥ 1 month prior to screening.
  4. IGA score of 2 or 3 (mild or moderate) during screening and baseline.
  5. Women of child bearing potential must have a negative urine pregnancy test atscreening and use an adequate contraceptive method throughout the study. Women ofchild bearing potential is defined as any female who has experienced menarche and whohas not undergone surgical sterilization (such as: hysterectomy or bilateraloophorectomy) and is not postmenopausal. Menopause is defined as 24 months ofamenorrhea in a woman over age 45 years in the absence of other biological orphysiological causes. Adequate method of birth control is defined as one of thefollowing: oral or injectable contraceptives, intrauterine device, contraceptiveimplants, tubal ligation, hysterectomy, or a double-barrier method (diaphragm withspermicidal foam or jelly, or a condom), abstinence or vasectomy. Males with partnersof childbearing potential should inform them of their participation in this clinicalstudy and use an adequate contraceptive method throughout the study.
  6. Willing and able to comply with study instructions and commit to attending all visits.
  7. The patient/parent/guardian has the ability to understand, agree to and sign the studyInformed 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.

Exclusion

Exclusion Criteria:

  1. Unstable or actively infected atopic dermatitis.
  2. Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contactdermatitis, psoriasis, etc.) or other medical condition(s) which may interfere withthe investigator's ability to evaluate the subject's response to study drug.
  3. Patients with Atopic Dermatitis affecting only the scalp will be excluded from thestudy. In addition, patients with the scalp representing ≥ 25% of the affected areawill be excluded as well.
  4. Has received treatment two weeks prior to visit 2 (Day 1 of IP) with topicalcorticosteroids 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 toreceive treatment during the study timeframe with immunosuppressive drugs and/orcorticosteroids (topical or systemic).
  5. Use of Crisaborole two weeks prior to visit 2 (Day 1 of IP).
  6. Prior use of Dupilumab.
  7. Subjects who are using any concomitant medications that, in the investigator'sopinion, could affect the subject's atopic dermatitis (e.g Antihistamines). Subjectsusing such medications and have been stable on treatment for at least one month priorto 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.
  8. Subject had UVA or UVB therapy two weeks prior to visit 2 (Day 1 of IP) or is due tohave it during the study period.
  9. Any vaccination in the last 30 days prior to the screening visit. However, due toCOVID-19 pandemic, only 1st vaccination for COVID is not allowed during only 21 daysprior to visit 2 (Day 1 of IP) and during the study. The 2nd vaccination onwards isallowed at all times.
  10. Abnormal renal function (defined as serum creatinine >1.5xULN).
  11. Abnormal liver function (defined as any transaminases >2xULN).
  12. Clinically significant abnormalities as determined by the Investigator on the 12-leadECG conducted at the screening visit (for adults only).
  13. Subject has active or history of malignancy, except non melanomatous skin cancer curedby excision. Subjects with past malignancy who had completed therapy and are free ofthe disease for at least 5 years may be included in the study, at the investigator'sdiscretion.
  14. History of immunodeficiency syndrome (e.g. atypical rash morphology, severe bacterial,fungal or viral skin infections, etc).
  15. Subjects who are receiving any investigational drug or who participated in a clinicaltrial with an investigational product within the last 30 days or 5-half-lives of theinvestigational product, whichever is longer.
  16. History of any anaphylactic reaction or history or evidence of allergies requiringacute or chronic treatment (except seasonal allergic rhinitis and atopic dermatitis).
  17. Known hypersensitivity to any of the components of the study drug.
  18. Known or suspected history of alcohol or drug abuse.
  19. Subjects with a history of human immunodeficiency virus (HIV) as determined by medicalhistory.
  20. Pregnant or lactating women.
  21. Any history which, in the Investigator's judgment, makes the subject ineligible orplaces the subject at undue risk.

Study Design

Total Participants: 165
Treatment Group(s): 3
Primary Treatment: ZEP-3Na 1%
Phase: 2
Study Start date:
December 29, 2019
Estimated Completion Date:
February 28, 2025

Study Description

165 subjects, 5-75 years old with mild to moderate Atopic Dermatitis will be enrolled to the study.

The investigational product which is the synthetic analogue of the natural compound found in the rattle snake venom will be administered topically twice daily.

The duration of the study will be up to 11 weeks consisting of up to 3 weeks of screening, 4 weeks of double blind treatment, optional 2 weeks of open label treatment, followed by 2 weeks of follow-up.

Efficacy will be measured by IGA (Investigator Global Assessment, EASI (Eczema Area and Severity Index) and SCORAD (SCORing Atopic Dermatitis).

Lesions will be photographed throughout the study. Physical examination and vital signs will be measured during every visit. Patients will complete quality of life questionnaires, itching scale and diaries.

Connect with a study center

  • Ha'Emek MC

    Afula,
    Israel

    Terminated

  • Barzilai MC

    Ashkelon,
    Israel

    Terminated

  • Rambam MC

    Haifa,
    Israel

    Active - Recruiting

  • Shaare Zedek MC

    Jerusalem,
    Israel

    Active - Recruiting

  • Clalit Health Services

    Kfar Saba,
    Israel

    Active - Recruiting

  • Meir MC

    Kfar Saba,
    Israel

    Site Not Available

  • Prof. Shemer Clinic affiliated to Laniado MC

    Netanya,
    Israel

    Active - Recruiting

  • Clalit Health Services

    Petah tikva,
    Israel

    Site Not Available

  • Clalit Health Services

    Ramla,
    Israel

    Site Not Available

  • Kaplan MC

    Reẖovot,
    Israel

    Active - Recruiting

  • Tel-Aviv Sourasky MC

    Tel Aviv,
    Israel

    Active - Recruiting

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