Protocols
The filing cabinet — every clinical protocol held in the library, with its current version, amendment history, and the study it belongs to.
Total
12
Active
5
Draft
1
Amended
2
Closed
2
Total MB
31.1
Acme Therapeutics
4 protocols- Active
Acemyebrelin 600 mg dose-expansion in r/r multiple myeloma
PROT-ONC-002 · STUDY-2025-001 · Phase 2b
Relapsed/refractory multiple myeloma
- Current version
- v3.0
- Last amended
- 2mo ago
- Amendments
- 3
- Size
- 2.3 MB
pdfdocxFiled by Dr. P. Adler (Medical Monitor) - In review
Acemyebrelin protocol amendment 4 — CrCl entry criterion relaxation
PROT-ONC-002-AMEND4 · STUDY-2025-001 · Phase 2b
Relapsed/refractory multiple myeloma
- Current version
- v3.1-draft
- Last amended
- 16d ago
- Amendments
- 0
- Size
- 1.9 MB
docxFiled by A. Bahari (Regulatory Lead) - Draft
First-in-human Ph1 SAD/MAD of brivomelin in healthy volunteers
PROT-NEU-021 · standalone · Phase 1
Healthy volunteer pharmacology — neurology programme
- Current version
- v0.4
- Last amended
- 12d ago
- Amendments
- 0
- Size
- 988.4 KB
docxFiled by Dr. P. Adler (Medical Monitor) - In review
Open-label Ph1b combination with checkpoint inhibitor in advanced NSCLC
PROT-ONC-004 · standalone · Phase 1
Advanced non-small-cell lung cancer (2L+)
- Current version
- v1.0
- Last amended
- 1mo ago
- Amendments
- 0
- Size
- 1.2 MB
pdfdocxFiled by S. Iyer (Sponsor Regulatory)
Helios Cardio
2 protocols- Active
Event-driven Ph3 CV outcomes study in post-MI elevated Lp(a)
PROT-CV-118 · STUDY-2023-021 · Phase 3
Reduction of MACE in post-MI patients with elevated Lp(a)
- Current version
- v5.2
- Last amended
- 10mo ago
- Amendments
- 5
- Size
- 6.1 MB
pdfdocxxmlFiled by J. Park (Sponsor Program Lead) - Active
Ph4 post-approval safety study of lorivastatin in primary prevention
PROT-CV-121 · standalone · Phase 4
Primary cardiovascular prevention — statin-naive adults
- Current version
- v2.0
- Last amended
- 8mo ago
- Amendments
- 2
- Size
- 2.0 MB
pdfxmlFiled by J. Park (Sponsor Program Lead)
Lyra Skin Sciences
1 protocol- Active
Combination device + topical Ph2a study in moderate-to-severe AD
PROT-DERM-003 · STUDY-2024-014 · Phase 2a
Moderate-to-severe atopic dermatitis (combination device)
- Current version
- v2.1
- Last amended
- 6mo ago
- Amendments
- 2
- Size
- 1.6 MB
pdfdocxFiled by Dr. N. Okafor (Sponsor PI)
Northwind Genetics
2 protocols- Amended
Pivotal Ph3 placebo-controlled study of velpoxetide in adult XLH
PROT-RARE-007 · STUDY-2025-002 · Phase 3
X-linked hypophosphatemia in adults
- Current version
- v4.0
- Last amended
- 3mo ago
- Amendments
- 4
- Size
- 4.2 MB
pdfdocxxmlFiled by L. Romero (Sponsor Regulatory) - Active
Natural history study of MPS-IIIb in paediatric subjects
PROT-RARE-009 · standalone · Observational
Mucopolysaccharidosis type IIIb (Sanfilippo-B) — paediatric
- Current version
- v1.2
- Last amended
- 6mo ago
- Amendments
- 1
- Size
- 1.8 MB
pdfdocxFiled by L. Romero (Sponsor Regulatory)
Stellis Vaccines
2 protocols- Amended
Adjuvanted RSV prefusion-F vaccine Ph2b dose-finding in older adults
PROT-VAX-014 · STUDY-2025-008 · Phase 2b
Respiratory syncytial virus in older adults
- Current version
- v2.3
- Last amended
- 4mo ago
- Amendments
- 3
- Size
- 2.9 MB
pdfdocxFiled by M. Chen (CMC Lead) - Closed
Closed-out Ph2a pandemic-flu adjuvant comparison
PROT-VAX-009 · standalone · Phase 2a
Pandemic influenza adjuvant comparison
- Current version
- v3.0-final
- Last amended
- 1y ago
- Amendments
- 3
- Size
- 2.7 MB
pdfdocxxmlFiled by M. Chen (CMC Lead)
Veridian Pharma
1 protocol- Closed
PASS 5-year safety registry of verexitide in T2DM
PROT-OBS-PMR-001 · STUDY-2022-009 · Observational
Long-term safety surveillance of verexitide in T2DM
- Current version
- v1.4-final
- Last amended
- 29d ago
- Amendments
- 4
- Size
- 3.4 MB
pdfxmlFiled by K. Reyes (Records Lead)