A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Disc Medicine, Inc
- Study ID
- NCT06985147
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Polycythemia Vera (PV)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- DISC-3405 — DRUGDISC-3405 is administered subcutaneously.
Study Details
This open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405 will assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of DISC-3405 in participants with polycythemia vera (PV).
Key Dates
- Start date
- Aug 12, 2025
- Status verified
- Sep 2025
- Primary completion
- Feb 28, 2027
- Completion
- Feb 28, 2029
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Within-participant dose escalationThis is an open-label, multicenter, within-participant dose escalation study examining up to 2 dose levels of DISC-3405.
Primary Outcome Measure
Number of participants with treatment-related adverse events as assessed by CTCAE [ Time Frame: Up to 365 days ]
Central Contacts
- Disc Medicine Clinical Trials(617) 674 9274
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | Jeanne Palmer, M.D. (PRINCIPAL_INVESTIGATOR) |
| UCLA Health | Los Angeles | California | 90095 | Gary Schiller, M.D. (PRINCIPAL_INVESTIGATOR) |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Caitlin O'Neill (PRINCIPAL_INVESTIGATOR) |
| Keck Medicine of USC - Cancer Clinic- Newport Beach | Newport Beach | California | 92663 | Caitlin O'Neill (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | Candido Rivera, M.D. (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic in Minnesota | Rochester | Minnesota | 55905 | Naseema Gangat, M.B.B.S. (PRINCIPAL_INVESTIGATOR) |
| Siteman Cancer Center - Washington University St. Louis | St Louis | Missouri | 63110 | Stephen Oh (PRINCIPAL_INVESTIGATOR) |
| Atrium Health - Levine Cancer Center | Charlotte | North Carolina | 28204 | Anne Wofford (PRINCIPAL_INVESTIGATOR) Michael Grunwald (SUB_INVESTIGATOR) |
| Duke University | Durham | North Carolina | 27705 | Lindsay Rein, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Anne Wofford (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Bren Chua Aaron Gerds, MD (PRINCIPAL_INVESTIGATOR) |
| Ohio State University | Columbus | Ohio | 43210 | Jennifer E Vaughn, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health & Science University | Portland | Oregon | 97239 | Joseph Shatzel (PRINCIPAL_INVESTIGATOR) |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Naveen Pemmaraju, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Washington - Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | Anna Halpern (PRINCIPAL_INVESTIGATOR) |
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