Trial · NCT03304379

Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

NCT03304379, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2023-02-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip. Trials, record NCT03304379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03304379

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
NCT number: NCT03304379
Status: Completed
Phases: Phase 3
Enrollment: 1,650 participants, actual
Lead sponsor: Regeneron Pharmaceuticals
Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip
Interventions: Fasinumab, Diclofenac, Celecoxib, Matching placebo
First posted: 2017-10-09
Last updated: 2023-02-24
Other registries' IDs: eudract:2017-001702-15
Results first posted: 2023-02-24

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Primary	Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
Secondary	Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Secondary	Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Secondary	Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs	Baseline up to Week 24	WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Secondary	Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs	Baseline up to Week 24	Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
Secondary	Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs	Baseline up to Week 24	The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Secondary	Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale	Baseline up to Week 24	Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.
Secondary	Number of Participants With Adjudicated Arthropathy (AA) Events	Baseline up to follow-up period (Week 44)	AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Secondary	Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria	Baseline up to follow-up period (Week 44)	DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, Number of Subjects Analysed signifies those subjects who were evaluable for this endpoint. Modified full analysis set (mFAS) includes all randomized participants in FAS but excludes participants from 4 sites for which there were potential concerns regarding data quality, identified prior to database lock.	Score on a Scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	The FAS included all randomized participants excluding participants affected by the urgent safety measure and was based on the treatment allocated (as randomized). As pre-specified in the protocol, efficacy data from participants randomized to Fasinumab 1 mg Q4W and placebo was only included in the analysis for this outcome measure.	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Baseline up to Week 24	This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs	Baseline up to Week 24	This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs	Baseline up to Week 24	This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, Number of Subjects Analysed signifies those subjects who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs	Baseline up to Week 24	This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale	Baseline up to Week 24	This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Here, Number of Participants Analyzed signifies those participants who were evaluable for this endpoint.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Adjudicated Arthropathy (AA) Events	Baseline up to follow-up period (Week 44)	This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Safety Analysis set (SAF) included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria	Baseline up to follow-up period (Week 44)	This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. Here, Number of Participants Analyzed signifies those participants who had positive AA.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 18Source ClinicalTrials.gov

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Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Placebo	FAS	-2.21	Standard Error 0.165	Score on a Scale
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Fasinumab 1 mg	FAS	-2.84	Standard Error 0.127	Score on a Scale
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Placebo	mFAS	-2.01	Standard Error 0.182	Score on a Scale
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Fasinumab 1 mg	mFAS	-2.78	Standard Error 0.141	Score on a Scale
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Placebo	FAS	-2.02	Standard Error 0.164	Score on a Scale
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Fasinumab 1 mg	FAS	-2.65	Standard Error 0.125	Score on a Scale
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Placebo	mFAS	-1.80	Standard Error 0.180	Score on a Scale
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo	Fasinumab 1 mg	mFAS	-2.62	Standard Error 0.138	Score on a Scale
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo	Placebo		48.7		Percentage of Participants
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo	Fasinumab 1 mg		59.8		Percentage of Participants

1 to 10 of 64Source ClinicalTrials.gov

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Participant flow35

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	308
Overall Study	STARTED	NSAIDs	612
Overall Study	STARTED	Fasinumab 1 mg	612
Overall Study	STARTED	Fasinumab 3 mg	59
Overall Study	STARTED	Fasinumab 6 mg	59
Overall Study	Full Analysis Set (FAS)	Placebo	308
Overall Study	Full Analysis Set (FAS)	NSAIDs	612
Overall Study	Full Analysis Set (FAS)	Fasinumab 1 mg	612
Overall Study	Full Analysis Set (FAS)	Fasinumab 3 mg	0
Overall Study	Full Analysis Set (FAS)	Fasinumab 6 mg	0

1 to 10 of 35Source ClinicalTrials.gov

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Adverse events430

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Placebo	48	309	113
other	Headache	Nervous system disorders	NSAIDs	107	609	210
other	Headache	Nervous system disorders	Fasinumab 1mg Q4W	95	609	224
other	Headache	Nervous system disorders	Fasinumab 3mg Q4W	2	58	2
other	Headache	Nervous system disorders	Fasinumab 6mg Q8W	2	59	2
other	Urinary tract infection	Infections and infestations	Placebo	25	309	29
other	Urinary tract infection	Infections and infestations	NSAIDs	35	609	39
other	Urinary tract infection	Infections and infestations	Fasinumab 1mg Q4W	50	609	57
other	Urinary tract infection	Infections and infestations	Fasinumab 3mg Q4W	1	58	1
other	Urinary tract infection	Infections and infestations	Fasinumab 6mg Q8W	2	59	2

1 to 10 of 430Source ClinicalTrials.gov

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Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	309
Total, all-cause mortality	NSAIDs	3	609
Total, all-cause mortality	Fasinumab 1mg Q4W	1	609
Total, all-cause mortality	Fasinumab 3mg Q4W	0	58
Total, all-cause mortality	Fasinumab 6mg Q8W	0	59
Total, other adverse events	Placebo	121	309
Total, other adverse events	NSAIDs	263	609
Total, other adverse events	Fasinumab 1mg Q4W	261	609
Total, other adverse events	Fasinumab 3mg Q4W	17	58
Total, other adverse events	Fasinumab 6mg Q8W	15	59

1 to 10 of 15Source ClinicalTrials.gov

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39004211	DERIVED	PubMed
40001000	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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