Clinical research study of a topical investigational medicine for adult patients with Netherton syndrome

Netherton syndrome is a rare disorder that affects skin, hair, and the immune system. Common manifestations include scaling skin, often in a pattern known as ichthyosis linearis circumflexa, and skin inflammation.

The investigational medicine, known as ATR12-351, is a topical ointment containing a modified bacterial strain that produces a critical part of the protein missing in Netherton syndrome.

If you have been diagnosed with Netherton syndrome and want to participate in this clinical study, you must meet these eligibility conditions:

• Male or female 18 years and older with skin changes consistent with Netherton syndrome, without large areas of open wounds or scratched areas
• Avoid certain kinds of medicines and therapies before and during the study
• Able to come to the study site for 2 weeks for twice daily application of the study drug; travel, hotel, and related expenses will be paid by the study sponsor
• Additional inclusion and exclusion criteria, which will be described by the study staff

When participating in a clinical trial, you are expected to follow study instructions. You will need to attend regularly scheduled visits, have examinations and lab tests, and answer questionnaires. This process aims to gather more information about you, your medical condition, and your experience in the study.

Participation in a clinical trial is voluntary, with study related examinations and tests performed at no cost to you or your medical insurer. You may withdraw from the study at any time with or without any given reason. You can read more about the study in the material provided to you during your screening visit.

Azitra Inc is sponsoring this clinical study with the guidance of FDA. Additional information is available at https://clinicaltrials.gov/study/NCT06137157, including current study site contact details.

Safety and effectiveness have not been established.

Study Contact
Name: Travis Whitfill
Phone Number:
203-646-6446
Email: clinicaltrials@azitrainc.com

This study has 1 location
United States
New Haven, Connecticut, United States, 06519

Recruiting
Yale University
Contact:
Nicole Study Coordinator
nicole.olszewski@yale.edu
Principal Investigator:
Leonard Milstone, MD