Trial Outcomes & Findings for A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II (NCT NCT04596540)

NCT ID: NCT04596540

Last Updated: 2025-12-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 153 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2025-12-03

Participant Flow

Participant milestones

Measure	SEL-212A (Low-dose) SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.	SEL-212B (High-dose) SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.
Overall Study STARTED	51	49	53
Overall Study Received at Least 1 Dose of Study Treatment	51	49	53
Overall Study COMPLETED	33	33	44
Overall Study NOT COMPLETED	18	16	9

Reasons for withdrawal

Measure	SEL-212A (Low-dose) SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.	SEL-212B (High-dose) SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.
Overall Study Lost to Follow-up	1	2	1
Overall Study Withdrawal by Subject	9	8	5
Overall Study Sponsor Decision	2	0	0
Overall Study Physician Decision	0	1	1
Overall Study Coronavirus Disease 2019 (COVID-19)	1	0	0
Overall Study Other Than Specified	5	5	2

Baseline Characteristics

A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II

Baseline characteristics by cohort

Measure	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	Total n=153 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 10.60 • n=3 Participants	56.4 years STANDARD_DEVIATION 9.70 • n=3 Participants	56.5 years STANDARD_DEVIATION 10.05 • n=6 Participants	55.4 years STANDARD_DEVIATION 10.16 • n=24 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	2 Participants n=3 Participants	1 Participants n=6 Participants	5 Participants n=24 Participants
Sex: Female, Male Male	49 Participants n=3 Participants	47 Participants n=3 Participants	52 Participants n=6 Participants	148 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	4 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=3 Participants	49 Participants n=3 Participants	52 Participants n=6 Participants	149 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=3 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	5 Participants n=3 Participants	2 Participants n=3 Participants	8 Participants n=6 Participants	15 Participants n=24 Participants
Race (NIH/OMB) White	45 Participants n=3 Participants	47 Participants n=3 Participants	44 Participants n=6 Participants	136 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=24 Participants

PRIMARY outcome

Timeframe: Month 6

Population: The Intent-to-Treat (ITT) Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Proportion of Participants Who Achieved and Maintained Reduction in Serum Uric Acid (sUA) < 6 Milligrams Per Deciliter (mg/dL) for At Least 80% of The Time During Treatment Period 6 (Month 6)	0.46 proportion of participants	0.11 proportion of participants	0.40 proportion of participants

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: The ITT Set, which included all randomized and dosed participants including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Change From Baseline in Mean sUA	-5.1 milligrams per deciliter (mg/dL) Standard Error 0.6	-0.6 milligrams per deciliter (mg/dL) Standard Error 0.5	-4.0 milligrams per deciliter (mg/dL) Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Percentage Change From Baseline in Mean sUA	-59.8 percentage change Standard Error 7.3	-6.2 percentage change Standard Error 6.3	-46.3 percentage change Standard Error 6.9

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

The SF-36 is a 36-item scale constructed to survey health status and quality of life (QoL). The SF-36 assesses 8 health concepts, which are the weighted sums of the questions in their section: 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. Each scale was directly transformed into a 0-100 scale, and the total average scores were calculated across the 8 health concepts. The 8 domains contribute to physical component summary and mental component summary scores. Total scores for the physical component summary score ranged from 0-100, with a higher score indicating better health outcomes.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Change From Baseline in the Physical Component Summary Score of the Short Form Health Survey (SF-36)	8.4 scores on a scale Standard Error 1.3	3.8 scores on a scale Standard Error 1.2	10.4 scores on a scale Standard Error 1.4

SECONDARY outcome

Timeframe: Baseline Up to 6 months

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. Here, overall number of participants analyzed = participants with tophi at baseline with evaluable data for the outcome measure.

Baseline photographs of the hands and feet of each participant were obtained using a standardized method in all participants, together with photographs of up to two other representative sites of tophaceous disease. The baseline photographs were assessed by three independent reviewers to prospectively identify sites of tophaceous disease present at the start of treatment. Up to five tophi in the photographs were chosen by the reviewers for measurement over the course of therapy. The reviewers assessed the photographs for size of each target tophus using image analysis software. At least PR was defined as at least a 50% decrease in the area of at least one tophus, and includes participants with complete response (CR). Data are presented for the proportion of participants with at least PR (as best response) in overall tophus response evaluation.

Outcome measures

Measure	SEL-212B (High-dose) n=33 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=36 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=34 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Proportion of Participants With at Least Partial Response (PR) (as Best Response) in Overall Tophus Response Evaluation in Participants With Tophi at Baseline	0.93 proportion of participants Interval 0.91 to 0.94	0.54 proportion of participants Interval 0.52 to 0.56	0.83 proportion of participants Interval 0.81 to 0.85

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment. Here, overall number of participants analyzed = participants with tophi at baseline with evaluable data for the outcome measure.

The number of responders in the subgroup of ITT participants with tophi at baseline divided by the number of ITT participants with tophi at baseline.

Outcome measures

Measure	SEL-212B (High-dose) n=33 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=36 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=34 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Proportion of Participants Who Achieved and Maintained Reduction of sUA < 6 mg/dL for at Least 80% of the Time During Month 6 in the Subset of Participants With Tophi at Baseline	0.45 proportion of participants Interval 0.44 to 0.47	0.11 proportion of participants Interval 0.1 to 0.11	0.38 proportion of participants Interval 0.38 to 0.39

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

Tender and/or swollen joints were counted. The following joints were assessed: metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints of the hands; the metatarsophalangeal and interphalangeal joints of the feet; shoulder, elbow, wrist, knee, ankle, tarsus, sternoclavicular, and acromioclavicular joints. Data are presented for the mean change from baseline in number of tender joints.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Change From Baseline to Month 6 in Number of Tender Joints	-8.1 tender joints Standard Error 0.9	-4.4 tender joints Standard Error 0.8	-9.2 tender joints Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

The HAQ-DI assesses fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both the upper and lower extremities. It includes 20 items in 8 categories: "activity", "arising", "dressing and grooming", "eating", "grip", "hygiene", "reach", and "walking". Scoring within each section was on a 4-point Likert scale from 0 (without any difficulty) to 3 (unable to do), with higher scores showing more disability. The average of the 8 category scores was reported as the HAQ-DI total score on a scale of 0 to 3, with higher scores showing more disability. Data are reported for change from baseline to Month 6 in the total HAQ-DI score. A decrease in HAQ-DI score from baseline indicated an improvement in the participant's condition.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Change From Baseline to Month 6 in the Total Score of the Health Assessment Questionnaire Disability Index (HAQ-DI)	-0.4 scores on a scale Standard Error 0.1	-0.3 scores on a scale Standard Error 0.1	-0.6 scores on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Months 1-6

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

Gout flare was assessed as part of adverse event (AE) collection. Gout flares were assessed during the Treatment Phase using a validated definition of flares in participants with established gout. A gout flare (per Gaffo et al. 2018) was defined as the fulfilment of at least 3 of the following 4 criteria: 1. Participant-defined gout flare, 2. Pain at rest score of >3 on a 0-10-point numerical rating scale, 3. Presence of at least 1 swollen joint, 4. Presence of at least 1 warm joint. Data are presented for the mean incidence per month of gout flares during Treatment Periods 1-6 (Months 1-6). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Incidence of Gout Flare During Treatment Periods 1-6 (Months 1-6)	0.1 gout flares/month Standard Error 0.0	0.1 gout flares/month Standard Error 0.0	0.1 gout flares/month Standard Error 0.0

SECONDARY outcome

Timeframe: Months 1-3

Population: The ITT Set, which included all randomized and dosed participants, including participants with missing data that were multiple imputed. Participants were analyzed according to randomized treatment.

Gout flare was assessed as part of adverse event (AE) collection. Gout flares were assessed during the Treatment Phase using a validated definition of flares in participants with established gout. A gout flare (per Gaffo et al. 2018) was defined as the fulfilment of at least 3 of the following 4 criteria: 1. Participant-defined gout flare, 2. Pain at rest score of >3 on a 0-10-point numerical rating scale, 3. Presence of at least 1 swollen joint, 4. Presence of at least 1 warm joint. Data are presented for the mean incidence per month of gout flares during Treatment Periods 1-3 (Months 1-3). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Outcome measures

Measure	SEL-212B (High-dose) n=49 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.	SEL-212A (Low-dose) n=51 Participants SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.
Incidence of Gout Flare During Treatment Periods 1-3 (Months 1-3)	0.2 gout flares/month Standard Error 0.1	0.2 gout flares/month Standard Error 0.1	0.1 gout flares/month Standard Error 0.1

Adverse Events

SEL-212A (Low-dose)

Serious events: 5 serious events

Other events: 28 other events

Deaths: 0 deaths

SEL-212B (High-dose)

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	SEL-212A (Low-dose) n=51 participants at risk SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.	SEL-212B (High-dose) n=49 participants at risk SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 participants at risk Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.
Infections and infestations COVID-19	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	1.9% 1/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Infections and infestations Infected gouty tophus	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Infections and infestations Pneumonia	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Infections and infestations Staphylococcal sepsis	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Cardiac disorders Acute myocardial infarction	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Cardiac disorders Angina pectoris	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.0% 1/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	1.9% 1/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Gastrointestinal disorders Enteritis	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Immune system disorders Anaphylactic reaction	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	4.1% 2/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Renal and urinary disorders Acute kidney injury	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.0% 1/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.

Other adverse events

Measure	SEL-212A (Low-dose) n=51 participants at risk SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 milligrams per kilogram (mg/kg) via intravenous (IV) infusion immediately after receiving SEL-110 at a dose of 0.1 mg/kg (SEL-212A) every 28 days for approximately six months.	SEL-212B (High-dose) n=49 participants at risk SEL-212 is comprised of 2 components: SEL-037 and SEL-110. Participants received SEL-037 administered at a dose of 0.2 mg/kg via IV infusion immediately after receiving SEL-110 at a dose of 0.15 mg/kg (SEL-212B) every 28 days for approximately six months.	Placebo n=53 participants at risk Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months.
Metabolism and nutrition disorders Hyperglycaemia	5.9% 3/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	4.1% 2/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.7% 3/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Metabolism and nutrition disorders Gout	35.3% 18/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	36.7% 18/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	34.0% 18/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Metabolism and nutrition disorders Dyslipidaemia	5.9% 3/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	6.1% 3/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	7.5% 4/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Infections and infestations COVID-19	3.9% 2/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	6.1% 3/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	7.5% 4/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Infections and infestations Nasopharyngitis	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	4.1% 2/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.7% 3/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Infusion related reaction	5.9% 3/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	6.1% 3/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Vascular disorders Hypertension	0.00% 0/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	6.1% 3/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.7% 3/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Blood and lymphatic system disorders Anaemia	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	6.1% 3/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Renal and urinary disorders Microalbuminuria	2.0% 1/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.7% 3/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Skin and subcutaneous tissue disorders Rash	5.9% 3/51 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/49 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/53 • Up to approximately 6 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.

Additional Information

Blank Clinical Study Physician, MD

Swedish Orphan Biovitrum AB (publ)

Phone: +46 8 697 20 00

Email: medical.info@sobi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place