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

Conditions

• Congenital Erythropoietic Porphyria (CEP)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ATL-001 (Ciclopirox oral solution) — DRUG
  Daily administration of oral ATL-001

Study Details

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

Key Dates

Start date

Jan 29, 2026

Status verified

Mar 2026

Primary completion

May 1, 2028

Completion

Jun 1, 2028

Study Design

Enrollment

6 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: ATL-001

Primary Outcome Measure

To evaluate the efficacy of ATL-001 in patients with CEP in terms of change in lesions associated with photosensitivity. [ Time Frame: From Baseline to 12 weeks intervals until the end of study (48 weeks) ]

Central Contacts

• Cristina Garrido
  +34 688 849 117
  [email protected]
• Mireia Pujals
  +34 688 849 117
  [email protected]

Locations (1)

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