NCT07024316 A Study to Investigate the Improvement of Photosensitivity in Terms of Skin Lesions Associated With CEP Following Administration of Oral ATL-001 (Ciclopirox Oral Solution) in Participants Aged >18 Years of Age With CEP
| NCT ID | NCT07024316 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Atlas Molecular Pharma |
| Condition | Congenital Erythropoietic Porphyria (CEP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2026-01-29 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a study to investigate the effect of oral ATL-001 (ciclopirox) in CEP (Congenital Erythropoietic Porphyria) patients. During the study, it will be measured the improvement of skin lesions, fatigue and other clinical symptoms as well as blood parameters. Funding source - FDA OOPD
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older at the time of signing the informed consent form (ICF) 2. Diagnosis of CEP, based on medical history and/or biochemical porphyrin analysis. Sponsor will review the CEP diagnostic criteria (medical history or biochemical porphyrin analysis) of each potential patient, written Sponsor approval before starting the run-in period will be required 3. a) Female participants must not be pregnant or lactating at screening or admission 3\. b) Female participants must be of nonchildbearing potential or agree to use 2 adequate forms of highly effective method(s) of contraception throughout the entire duration of study participation and for at least 4 weeks after the last dose of any study intervention and have negative pregnancy test results at screening (serum) and admission (urine) 4. Male participants with female partners of childbearing potential must be surgically sterile (successful vasectomy at least 4 weeks prior to Day 1) or agree to use adequate forms of highly effective contraception (together with their female partner) for the duration of the study and for at least 4 weeks after the last dose of study intervention; must also agree to refrain from sperm donation during the study and for at least 4 weeks after the last dose of study intervention 5. Negative pregnancy test (females of childbearing potential) at Screening (Month -6), at Baseline (Day 1) and at every visit site until EoS prior to dosing 6. Able to understand the study aims, procedures, and requirements, and provide written informed consent 7. Able to comply with all study procedures 8. Able and committed to complete study patient diaries and questionnaires Exclusion Criteria: 1. Other than CEP, an inherited or acquired red cell disease associated with anemia 2. Any other photodermatosis such as solar urticaria 3. A history or known allergic reaction to any investigational product excipients or the investigational drug 4. Major surgery within 8 weeks before Screening, incomplete recovery from any previous surgery or planned major surgery during the study 5. History of alcohol dependence or excessive alcohol consumption, as assessed by the Investigator 6. Human immunodeficiency virus (HIV), active Hepatitis B, or C. A positive hepatitis result should be discussed between the Investigator and Sponsor prior to enrolment 7. Score of Personal Health Questionnaire Depression Scale (PHQ-8) ≥10 at screening or any response of "yes" on the Columbia-Suicide Severity Rating Scale (C-SSRS) 8. Uncontrolled medical condition or concomitant medication that would confound the ability to interpret clinical, clinical laboratory, or participant diary data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months 9. Administration of afamelanotide and dersimelagon within the last 2 months prior to start of the run-in period 10. Total bilirubin \>2× ULN (unless documented Gilbert syndrome) at Screening 11. If female, pregnant or breastfeeding. Final\_V2.1 38 of 106 11 Apr 2025 12. Participation in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07024316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Congenital Erythropoietic Porphyria (CEP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07024316 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07024316 currently recruiting?
Yes, NCT07024316 is actively recruiting participants. Contact the research team at cgarrido@atlasmolecularpharma.com for enrollment information.
Where is the NCT07024316 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07024316 clinical trial?
NCT07024316 is sponsored by Atlas Molecular Pharma. The trial plans to enroll 6 participants.