NCT07187973 A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)
| NCT ID | NCT07187973 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Disc Medicine, Inc |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2027-06 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is an open-label, multicenter, within-participant dose-escalation study examining up to 3 dose levels of DISC-3405 and will assess the safety, tolerability, PK, and PD of DISC 3405 in participants with sickle cell disease.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older at the time of signing the informed consent form (ICF). 2. Male or female study participants with SCD HbSC or HbSS. 3. Participants who have been diagnosed with any of the following SCD-related complications: between 1-10 episodes of VOC in the past 12 months, any history of sickle cell related retinopathy, silent cerebral infarct, avascular necrosis, sensorineural hearing loss; or at least 1 episode of priapism, hepatic sequestration, splenic sequestration, or splenic infarct within the last 12 months as assessed locally. 4. Hgb ≥7.0 g/dL during Screening. The first 2 participants must have an Hgb ≥9 g/dL. 5. Normal alpha globin gene screen. 6. Absolute reticulocyte count or % reticulocyte count \>1.5 × upper limit of normal (ULN) during Screening. 7. TSAT ≥15% at Screening. 8. Ferritin ≥50 ng/mL for HbSC or ≥100 ng/mL for HbSS (ferritin must be \<1000 ng/mL at Screening). 9. For participants taking hydroxyurea, L-glutamine, or crizanlizum
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