Trial Outcomes & Findings for Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (NCT NCT01459796)

Last Updated: 2017-07-18

Results Overview

Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

220 participants

Primary outcome timeframe

Day 1 to Day 392 (Week 56)

Results posted on

2017-07-18

Participant Flow

The study was conducted at 60 study sites in the United States (US) from 12 November 2011 to 02 November 2012. A total of 485 participants were screened in the study.

Out of 485 participants, 220 were randomized and treated in the study. Participants were randomized in 4:3 ratio to receive either Rilonacept 80 mg or Placebo.

Participant milestones

Participant milestones
Measure	Placebo Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51.	Rilonacept 80 mg Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
Overall Study STARTED	94	126
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	94	126

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51.	Rilonacept 80 mg Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
Overall Study Non compliance with protocol	2	4
Overall Study Adverse Event	5	5
Overall Study Withdrawal by Subject	6	3
Overall Study Lost to Follow-up	5	4
Overall Study Reason unspecified	1	2
Overall Study Decision by the sponsor	75	108

Baseline Characteristics

Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=94 Participants Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.	Rilonacept 80 mg n=126 Participants Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.	Total n=220 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 10.69 • n=5 Participants	52.1 years STANDARD_DEVIATION 11.18 • n=7 Participants	51.9 years STANDARD_DEVIATION 10.95 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	111 Participants n=7 Participants	197 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	120 Participants n=7 Participants	207 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	27 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	87 Participants n=7 Participants	162 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 392 (Week 56)

Population: Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.	Rilonacept 80 mg n=126 Participants Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) With at least one TEAE	68.1 percentage of participants	68.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) With TEAEs related to study drug	12.8 percentage of participants	19.0 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) With serious TEAEs	5.3 percentage of participants	4.0 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) With TEAEs resulting in study drug discontinuation	10.6 percentage of participants	6.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) With TEAEs resulting in death	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Day 1 to Day 168 (Week 24)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Day 168 (Week 24)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Day 364 (Week 52)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Day 364 (Week 52)

Population: As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.

Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Day 364 (Week 52)

Population: Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).

Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.

Outcome measures

Outcome measures
Measure	Placebo n=94 Participants Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.	Rilonacept 80 mg n=126 Participants Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)	22.3 percentage of participants	8.7 percentage of participants

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

Rilonacept 80 mg

Serious events: 5 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=94 participants at risk Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.	Rilonacept 80 mg n=126 participants at risk Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
Cardiac disorders Myocardial infarction	0.00% 0/94 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.79% 1/126 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
General disorders Drug interaction	1.1% 1/94 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.00% 0/126 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Infections and infestations Cellulitis	1.1% 1/94 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.79% 1/126 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/94 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.79% 1/126 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Injury, poisoning and procedural complications Limb traumatic amputation	1.1% 1/94 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.00% 0/126 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.00% 0/94 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.79% 1/126 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Psychiatric disorders Schizoaffective disorder	1.1% 1/94 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.00% 0/126 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Psychiatric disorders Suicidal ideation	1.1% 1/94 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.00% 0/126 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Renal and urinary disorders Nephrolithiasis	0.00% 0/94 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.79% 1/126 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/94 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	0.79% 1/126 • Number of events 1 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).

Other adverse events

Other adverse events
Measure	Placebo n=94 participants at risk Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 51.	Rilonacept 80 mg n=126 participants at risk Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
Gastrointestinal disorders Diarrhoea	3.2% 3/94 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	7.1% 9/126 • Number of events 9 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Gastrointestinal disorders Nausea	5.3% 5/94 • Number of events 23 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	1.6% 2/126 • Number of events 2 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
General disorders Injection site erythema	2.1% 2/94 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	7.1% 9/126 • Number of events 27 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Infections and infestations Nasopharyngitis	3.2% 3/94 • Number of events 3 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	6.3% 8/126 • Number of events 8 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Infections and infestations Upper respiratory tract infection	3.2% 3/94 • Number of events 4 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	7.9% 10/126 • Number of events 12 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Musculoskeletal and connective tissue disorders Arthralgia	9.6% 9/94 • Number of events 10 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	7.1% 9/126 • Number of events 9 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Musculoskeletal and connective tissue disorders Pain in extremity	6.4% 6/94 • Number of events 7 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	5.6% 7/126 • Number of events 9 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Nervous system disorders Headache	6.4% 6/94 • Number of events 11 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	8.7% 11/126 • Number of events 55 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).
Vascular disorders Hypertension	2.1% 2/94 • Number of events 5 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).	6.3% 8/126 • Number of events 8 • Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 56) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). Analysis was performed on safety analysis set (SAF).

Additional Information

Clinical Trial Management

Regeneron Pharmaceuticals, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI/Institution will provide a copy of any publication to Sponsor prior to submission for review. Sponsor may request to remove confidential information from submission, provided that removal does not preclude the complete and accurate presentation and interpretation of the study results.
Publication restrictions are in place

Restriction type: OTHER