Trial Outcomes & Findings for A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy (NCT NCT03905512)
NCT ID: NCT03905512
Last Updated: 2023-10-17
Results Overview
The average of the data collected during Month 3 and Month 6 was reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
170 participants
Primary outcome timeframe
Up to Month 6
Results posted on
2023-10-17
Participant Flow
Participants were enrolled across clinical sites in the United States.
Participant milestones
| Measure |
SEL-212
Participants received SEL-212 via intravenous (IV) infusion every 28 days for up to 6 months
|
KRYSTEXXA
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
87
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
83
|
87
|
|
Overall Study
COMPLETED
|
62
|
70
|
|
Overall Study
NOT COMPLETED
|
21
|
17
|
Reasons for withdrawal
| Measure |
SEL-212
Participants received SEL-212 via intravenous (IV) infusion every 28 days for up to 6 months
|
KRYSTEXXA
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Other than Specified
|
7
|
4
|
Baseline Characteristics
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
Baseline characteristics by cohort
| Measure |
SEL-212
n=83 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.6 years
STANDARD_DEVIATION 11.47 • n=99 Participants
|
52.0 years
STANDARD_DEVIATION 10.43 • n=107 Participants
|
52.3 years
STANDARD_DEVIATION 10.92 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Population: ITT set included all randomized participants.
The average of the data collected during Month 3 and Month 6 was reported.
Outcome measures
| Measure |
SEL-212
n=83 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Number of Participants With Serum Uric Acid (SUA) Reduction of < 6 mg/dL for at Least 80% of the Time
|
44 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: ITT set included all randomized participants.
Outcome measures
| Measure |
SEL-212
n=83 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Number of Participants With SUA Reduction of < 6 mg/dL for At Least 80% of the Time During Month 6
|
45 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: ITT set included all randomized participants.
Outcome measures
| Measure |
SEL-212
n=83 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Number of Participants With SUA Reduction of < 6 mg/dL for 100% of the Time During Month 6
|
38 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline to End of Month 3, Baseline to End of Month 6Population: ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
Eight categories were assessed by the HAQ-DI: 1) dressing and grooming, 2) arising, 3) eating, 4) walking, 5) hygiene, 6) reaching, 7) gripping, and 8) common daily activities. There were 2 or 3 questions for each category. Scoring within each category was on a 4-point Likert scale from 0 (without any difficulty) to 3 (unable to do). The score given to each section was the worst (highest) score within the section. The HAQ-DI total score was calculated if 6 or more sections were available. The average of the 8 category scores was reported as the HAQ-DI total score on a scale of 0 to 3. Reduction from baseline, and lower scores indicated better QoL.
Outcome measures
| Measure |
SEL-212
n=82 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=83 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
Baseline
|
0.78 score on a scale
Standard Deviation 0.774
|
0.79 score on a scale
Standard Deviation 0.834
|
|
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
Change at End of Month 3
|
-0.14 score on a scale
Standard Deviation 0.725
|
-0.10 score on a scale
Standard Deviation 0.795
|
|
Quality of Life (QoL) as Assessed by Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scale
Change at End of Month 6
|
0.04 score on a scale
Standard Deviation 0.723
|
-0.12 score on a scale
Standard Deviation 0.739
|
SECONDARY outcome
Timeframe: Baseline to End of Month 3, Baseline to End of Month 6Population: ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
The PrGA was administered to assess the severity of the participant's disease on a scale from 0 (participant feels "very well") to 100 (participant feels "very poor"). Reduction from baseline, and lower scores indicated less severe disease.
Outcome measures
| Measure |
SEL-212
n=78 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=81 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale
Change at End of Month 6
|
-24.6 score on a scale
Standard Deviation 24.87
|
-22.0 score on a scale
Standard Deviation 29.37
|
|
QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale
Baseline
|
42.8 score on a scale
Standard Deviation 26.65
|
40.5 score on a scale
Standard Deviation 28.62
|
|
QoL as Assessed by Change From Baseline in Provider Global Assessment of Disease Activity (PrGA) Scale
Change at End of Month 3
|
-20.9 score on a scale
Standard Deviation 25.38
|
-15.8 score on a scale
Standard Deviation 32.97
|
SECONDARY outcome
Timeframe: Baseline to End of Month 3, Baseline to End of Month 6Population: ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
The SF-36 is a 36-item questionnaire to assesses a participant's health status using 8 health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The mental component reports the average of all the emotionally relevant items and the physical component reports the average of all the physical relevant items. Each component is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 indicates no disability. Median change can range from -100 to 100. A positive median change indicated an improved outcome.
Outcome measures
| Measure |
SEL-212
n=81 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=84 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Physical Component Scores at Baseline
|
43.822 score on a scale
Standard Deviation 10.9976
|
43.345 score on a scale
Standard Deviation 11.2714
|
|
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Change in Physical Component Scores at End of Month 3
|
3.323 score on a scale
Standard Deviation 9.9242
|
5.768 score on a scale
Standard Deviation 9.0712
|
|
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Change in Physical Component Scores at End of Month 6
|
5.881 score on a scale
Standard Deviation 9.0453
|
7.448 score on a scale
Standard Deviation 8.3909
|
|
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Mental Component Scores at Baseline
|
51.977 score on a scale
Standard Deviation 8.4731
|
53.386 score on a scale
Standard Deviation 9.3171
|
|
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Change in Mental Component Scores at End of Month 3
|
0.381 score on a scale
Standard Deviation 6.7469
|
1.229 score on a scale
Standard Deviation 7.6445
|
|
QoL as Assessed by Change From Baseline in Short Form Health Survey 36 (SF-36) Scale
Change in Mental Component Scores at End of Month 6
|
1.516 score on a scale
Standard Deviation 6.4824
|
-0.322 score on a scale
Standard Deviation 8.0626
|
SECONDARY outcome
Timeframe: Month 1 to Month 3, Month 4 to Month 6Population: ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
Outcome measures
| Measure |
SEL-212
n=83 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Number of Participants With Gout Flares Per 3-Month Period
Month 1 to Month 3
|
50 Participants
|
42 Participants
|
|
Number of Participants With Gout Flares Per 3-Month Period
Month 4 to Month 6
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Month 1 to Month 3, Month 4 to Month 6Population: ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
Outcome measures
| Measure |
SEL-212
n=83 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Number of Gout Flares Per 3-Month Period
Month 1 to Month 3
|
1.1 number of flares
Standard Deviation 1.16
|
0.8 number of flares
Standard Deviation 1.24
|
|
Number of Gout Flares Per 3-Month Period
Mont 4 to Month 6
|
0.2 number of flares
Standard Deviation 0.56
|
0.3 number of flares
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline to End of Month 6Population: ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
Outcome measures
| Measure |
SEL-212
n=82 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Change From Baseline in Number of Tender Joints
Baseline
|
5.2 number of tender joints
Standard Deviation 8.81
|
4.1 number of tender joints
Standard Deviation 7.49
|
|
Change From Baseline in Number of Tender Joints
Change at End of Month 6
|
-2.4 number of tender joints
Standard Deviation 8.98
|
-2.7 number of tender joints
Standard Deviation 6.93
|
SECONDARY outcome
Timeframe: Baseline to End of Month 6Population: ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe.
Outcome measures
| Measure |
SEL-212
n=82 Participants
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 Participants
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Change From Baseline in Number of Swollen Joints
Baseline
|
3.0 number of swollen joints
Standard Deviation 5.39
|
3.7 number of swollen joints
Standard Deviation 6.64
|
|
Change From Baseline in Number of Swollen Joints
Change at End of Month 6
|
-1.6 number of swollen joints
Standard Deviation 5.51
|
-1.9 number of swollen joints
Standard Deviation 8.38
|
Adverse Events
SEL-212
Serious events: 7 serious events
Other events: 60 other events
Deaths: 0 deaths
KRYSTEXXA
Serious events: 8 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SEL-212
n=83 participants at risk
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 participants at risk
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.2%
1/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
1.2%
1/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.2%
1/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Nervous system disorders
Presyncope
|
1.2%
1/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
2/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
2/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
1.1%
1/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Vascular disorders
Thrombosis
|
1.2%
1/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
Other adverse events
| Measure |
SEL-212
n=83 participants at risk
Participants received SEL-212 via IV infusion every 28 days for up to 6 months
|
KRYSTEXXA
n=87 participants at risk
Participants received KRYSTEXXA® according to the manufacturer's prescribing information every 14 days for up to 6 months
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
5/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Injury, poisoning and procedural complications
Infusion Related reaction
|
15.7%
13/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
10.3%
9/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.2%
6/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
6.9%
6/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Nervous system disorders
Headache
|
7.2%
6/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Renal and urinary disorders
Hematuria
|
6.0%
5/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
0.00%
0/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Vascular disorders
Hypertension
|
7.2%
6/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
5.7%
5/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
|
Metabolism and nutrition disorders
Gout
|
60.2%
50/83 • Up to 7 months
Safety Set included all participants who received the study drug.
|
50.6%
44/87 • Up to 7 months
Safety Set included all participants who received the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place