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RN624

Phase 2

Neuralgia, Postherpetic | Small molecule | Pain |Pfizer, Inc.|Last Updated: May 28, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

RN624 · 3 trials · 4 indications

Phase 2 3
NCT00568321RN624 For Pain Of Post-Herpetic NeuralgiaNeuralgia, Postherpetic
COMPLETED99 Analytics
NCT00399490Open-label Extension Study Of RN624Osteoarthritis
COMPLETED287 Analytics
NCT00394563A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee PainOsteoarthritis
COMPLETED450 Analytics
PHASE2COMPLETED
RN624 For Pain Of Post-Herpetic Neuralgia
Neuralgia, PostherpeticUnlock trial analytics
PHASE2COMPLETED
Open-label Extension Study Of RN624
OsteoarthritisUnlock trial analytics
PHASE2COMPLETED
A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6
Baseline, Week 6

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 12 weeks after last dose of study drug

AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.

Walking knee pain scores
Day 112

Secondary Endpoints

Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Baseline, Week 1, 2, 4, 8, 12, 16
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16
Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16
Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3PLACEBO_COMPARATOR -
4EXPERIMENTAL -
5EXPERIMENTAL -
placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
RN624DRUG50 mcg/kg
PlaceboDRUGplacebo
RN624 (PF-04383119)DRUG50 mcg/kg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Male or female of any race, at least 18 years of age. * Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash. * Has a pain score at screening that qualifies. * Completes at least 3 average daily pain diaries during the 3 days prio...

Countries:United States
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Frequently asked questions about RN624

What is RN624 used for?

RN624 is an investigational small molecule being studied for pain, specifically for postherpetic neuralgia and osteoarthritis. It has been evaluated in Phase 2 clinical trials for moderate to severe osteoarthritis knee pain and for pain of post-herpetic neuralgia.

Who makes RN624?

RN624 is being developed by Pfizer, Inc. (NYSE: PFE). The company has sponsored Phase 2 clinical trials of the drug for pain indications including osteoarthritis and postherpetic neuralgia.

What phase is RN624 in?

RN624 is in Phase 2 clinical development. It has completed two Phase 2 trials, one for osteoarthritis knee pain and one for postherpetic neuralgia pain. It is not approved and remains investigational.

What clinical trials is RN624 in?

RN624 has been studied in three completed Phase 2 trials: NCT00394563 for moderate to severe osteoarthritis knee pain, NCT00399490 as an open-label extension study for osteoarthritis, and NCT00568321 for pain of post-herpetic neuralgia. All trials are completed.

How does RN624 work?

RN624 is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being studied for pain relief in conditions like osteoarthritis and postherpetic neuralgia.

Is RN624 the same as tanezumab?

RN624 is not the same as tanezumab. RN624 is a small molecule, while tanezumab is a monoclonal antibody. They are distinct drug candidates developed by Pfizer for pain indications.