A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Phase 2 Recruiting 10000 enrolled Eli Lilly and Company

RandomizedParallel-groupDouble-blindScreening

Summary

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Timeline

Start: 2020-01-30
Primary completion: 2027-04
Completion: 2027-04

Publications

Knopp KL, Downing AM, Anthony L, Chaterjee S, Price K, Sparks J. An innovative phase 2 chronic pain master protocol design to assess novel mechanisms in multiple pain types. Pain Rep. 2024 Oct 16;9(6):e1203. doi: 10.1097/PR9.0000000000001203. eCollection 2024 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fepixnebart	Monoclonal antibody	—	Intravenous
Subject	LY3526318	Unknown	—	Oral
Subject	LY3556050	Unknown	—	Oral
Subject	LY3857210	Unknown	—	Oral
Subject	LY4065967	Unknown	—	Oral

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Summary

Timeline

Publications

Drugs

Indications