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Fasinumab AI

Phase 1

Osteoarthritis, Knee | Small molecule | Musculoskeletal |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 3, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Fasinumab AI · 1 trial · 2 indications

Phase 1 1
NCT03491904To Assess the Patients' Ability to Self-Administer FasinumabOsteoarthritis, Knee
COMPLETED100 Analytics
PHASE1COMPLETED
To Assess the Patients' Ability to Self-Administer Fasinumab
Osteoarthritis, KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of device-associated product technical failure (PTF) for the AI based on the total number of fasinumab injections administered by patients/caregivers in an unsupervised setting
Baseline to Week 16

Secondary Endpoints

Proportion of successful fasinumab injections administered by patients or their caregivers using an AI in an unsupervised setting (per patient report)
Baseline to Week 16
Number of AI associated product technical complaint (PTCs)
Baseline to Week 16
Number of validated AI associated PTFs
Baseline to Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Auto-injector (AI)EXPERIMENTAL -
Prefilled syringe (PFS)EXPERIMENTAL -

Interventions

NameTypeDescription
Fasinumab AIDRUGSelf-administered with auto injector
Fasinumab PFSDRUGPrefilled syringe administered by study staff
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Key Inclusion Criteria: 1. A clinical diagnosis of Osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit 2. Moderate-to-severe pain in the index joint defined as a WOMAC ...

Countries:United States
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Frequently asked questions about Fasinumab AI

What is Fasinumab AI used for?

Fasinumab AI is an investigational small molecule being developed for osteoarthritis, specifically for osteoarthritis of the knee. It is currently in Phase 1 clinical development and is not approved for any use.

Who is developing Fasinumab AI?

Fasinumab AI is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker REGN. The drug is currently in Phase 1 clinical trials.

What phase is Fasinumab AI in?

Fasinumab AI is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is Fasinumab AI in?

Fasinumab AI has one completed Phase 1 clinical trial, identified as NCT03491904. This trial assessed patients' ability to self-administer the drug and enrolled 100 participants with osteoarthritis of the knee or hip in the United States.

Is Fasinumab AI the same as fasinumab?

Fasinumab AI is a distinct drug candidate from fasinumab. While both are being developed by Regeneron, Fasinumab AI is a small molecule in Phase 1 development for knee osteoarthritis, whereas fasinumab is a different investigational product.