Evaluating ZEP-3Na for treating mild to moderate Atopic Dermatitis

A Phase II Multicenter, Randomized, Double Blind Study to Assess the Safety, Tolerability and Efficacy of Two Concentrations of ZEP-3Na Topical Cream (0.1% and 1%) Compared to Vehicle-control in Subjects With Mild to Moderate Atopic Dermatitis With an Open Label Extension of up to 2 Weeks Treatment With ZEP-3Na Topical Cream 1%

This study is testing a new cream made from snake venom to see if it can help people aged 5 to 75 with mild to moderate eczema feel better and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 5 Years to 75 Years
• Sex: All
• Sponsor: Shulov Innovate for Science Ltd. 2012 (Industry-sponsored)
• Drugs / interventions: Dupilumab
• Locations: 10 sites (Afula and 9 other locations)
• Trial ID: NCT04307862 on ClinicalTrials.gov

What this trial studies

This phase II, double-blind clinical trial investigates the safety, tolerability, and efficacy of two concentrations of ZEP-3Na (0.1% and 1%) compared to a placebo in patients aged 5 to 75 with mild to moderate Atopic Dermatitis. Participants will apply the investigational product topically twice daily for four weeks, with those meeting primary endpoints having the option for an additional two weeks of open-label treatment. Efficacy will be assessed using various clinical scales and patient-reported outcomes, including quality of life questionnaires and itching scales. The study aims to provide insights into the therapeutic potential of a synthetic analogue derived from rattle snake venom.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 5 to 75 with a clinical diagnosis of mild to moderate Atopic Dermatitis present for at least three months.

Not a fit: Patients with severe Atopic Dermatitis or those who have not had stable disease for at least one month prior to screening may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from mild to moderate Atopic Dermatitis.

How similar studies have performed: While similar approaches have been explored, the specific use of ZEP-3Na as a synthetic analogue in this context is novel.

Eligibility criteria

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 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.
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 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.

Exclusion Criteria:

1. Unstable or actively infected atopic dermatitis.
2. 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.
3. 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.
4. 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).
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'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.
8. 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.
9. 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.
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-lead ECG conducted at the screening visit (for adults only).
13. 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.
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 clinical trial with an investigational product within the last 30 days or 5-half-lives of the investigational product, whichever is longer.
16. History of any anaphylactic reaction or history or evidence of allergies requiring acute 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 medical history.
20. Pregnant or lactating women.
21. Any history which, in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk.

Where this trial is running

Afula and 9 other locations

• 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 — Reẖovot, Israel (Recruiting)
• Tel-Aviv Sourasky MC — Tel Aviv, Israel (Recruiting)

Conditions Atopic Dermatitis