Trial Outcomes & Findings for A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy (NCT NCT04513366)

NCT ID: NCT04513366

Last Updated: 2025-09-11

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

Month 6

Results posted on

2025-09-11

Participant Flow

Participant milestones

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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Treatment Phase STARTED	37	38	37
Treatment Phase Received at Least 1 Dose of Study Treatment	37	38	37
Treatment Phase COMPLETED	27	27	26
Treatment Phase NOT COMPLETED	10	11	11
Extension Phase STARTED	27	27	26
Extension Phase Received at Least 1 Dose of Study Treatment	27	27	26
Extension Phase COMPLETED	19	23	22
Extension Phase NOT COMPLETED	8	4	4

Reasons for withdrawal

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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Treatment Phase Withdrawal by Subject	6	8	3
Treatment Phase Lost to Follow-up	1	2	5
Treatment Phase Other than Specified	1	0	2
Treatment Phase Physician Decision	2	0	0
Treatment Phase Adverse Event	0	1	1
Extension Phase Withdrawal by Subject	3	1	1
Extension Phase Other than Specified	4	0	1
Extension Phase Lost to Follow-up	1	1	1
Extension Phase Sponsor Decision	0	1	0
Extension Phase Death	0	1	0
Extension Phase Adverse Event	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Total n=112 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 10.55 • n=5 Participants	53.6 years STANDARD_DEVIATION 11.99 • n=7 Participants	53.6 years STANDARD_DEVIATION 10.57 • n=5 Participants	54.2 years STANDARD_DEVIATION 11.00 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	35 Participants n=7 Participants	37 Participants n=5 Participants	107 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	32 Participants n=7 Participants	27 Participants n=5 Participants	82 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	77 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Intent-to-Treat 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

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional 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)	0.48 proportion of participants	0.56 proportion of participants	0.04 proportion of participants

SECONDARY outcome

Timeframe: Baseline, Up to 6 months

Population: Intent-to-Treat 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

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Change From Baseline in Mean sUA	-5.1 mg/dL Standard Error 0.6	-5.5 mg/dL Standard Error 0.6	0.2 mg/dL Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline, Up to 6 months

Outcome measures

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Percentage Change From Baseline in Mean sUA	-58.7 percentage change Standard Error 8.0	-64.2 percentage change Standard Error 7.1	5.6 percentage change Standard Error 6.8

SECONDARY outcome

Timeframe: Baseline, Up to 6 months

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 contributed 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

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Change From Baseline in the Physical Component Summary Score of the Short Form Health Survey (SF-36)	7.4 score on a scale Standard Error 1.8	4.8 score on a scale Standard Error 1.7	3.0 score on a scale Standard Error 1.8

SECONDARY outcome

Timeframe: Baseline up to 6 months

Population: Intent-to-Treat Set, which included all randomized and dosed participants, including participants with missing outcome measure data that were multiple imputed. Participants were analyzed according to randomized treatment. Here, overall number of participants analyzed = participants with tophi at baseline and 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 2 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 5 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).

Outcome measures

Outcome measures
Measure	SEL-212A (Low-dose) n=21 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=22 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=21 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional 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	1.00 proportion of participants Confidence intervals could not be calculated as the estimated proportion was exactly 1.	0.67 proportion of participants Interval 0.61 to 0.73	0.42 proportion of participants Interval 0.39 to 0.45

SECONDARY outcome

Timeframe: Baseline up to 6 months

The number of responders in the subgroup of Intent-to-Treat participants with tophi at baseline divided by the number of Intent-to-Treat participants with tophi at baseline.

Outcome measures

Outcome measures
Measure	SEL-212A (Low-dose) n=21 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=22 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=21 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional 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	0.50 proportion of participants Interval 0.49 to 0.51	0.34 proportion of participants Interval 0.33 to 0.36	0.07 proportion of participants Interval 0.05 to 0.08

SECONDARY outcome

Timeframe: Baseline, Up to 6 months

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.

Outcome measures

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Change From Baseline to Month 6 in Number of Tender Joints	-2.1 tender joints Standard Error 0.3	-1.4 tender joints Standard Error 0.3	-1.9 tender joints Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline, Up to 6 months

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 score 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. A decrease in HAQ-DI score from baseline indicated an improvement in the participant's condition.

Outcome measures

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Change From Baseline to Month 6 in the Total Score of the Health Assessment Questionnaire Disability Index (HAQ-DI)	-0.2 score on a scale Standard Error 0.1	0.0 score on a scale Standard Error 0.1	-0.1 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Months 1-6

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 fulfillment 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 LS 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

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Incidence of Gout Flare During Treatment Periods 1-6 (Months 1-6)	0.2 gout flares/month Standard Error 0.1	0.4 gout flares/month Standard Error 0.1	0.3 gout flares/month Standard Error 0.1

SECONDARY outcome

Timeframe: Months 1-3

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 fulfillment 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 LS 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

Outcome measures
Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 Participants Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Incidence of Gout Flare During Treatment Periods 1-3 (Months 1-3)	0.4 gout flares/month Standard Error 0.1	0.4 gout flares/month Standard Error 0.1	0.3 gout flares/month Standard Error 0.1

Adverse Events

SEL-212A (Low-dose)

Serious events: 10 serious events

Other events: 31 other events

Deaths: 0 deaths

SEL-212B (High-dose)

Serious events: 5 serious events

Other events: 29 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Blank Clinical Study Physician, MD

Swedish Orphan Biovitrum AB (publ)

Phone: +46 8 697 20 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 participants at risk Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Infections and infestations Pneumonia	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 Sepsis	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 pneumonia	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.7% 1/37 • Day 1 up to approximately 12 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 Cellulitis	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 Clostridium difficile colitis	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 Periodontitis	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Nervous system disorders Presyncope	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Nervous system disorders Subarachnoid haemorrhage	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Hepatobiliary disorders Cholelithiasis	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 Road traffic accident	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Vascular disorders Deep vein thrombosis	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.

Measure	SEL-212A (Low-dose) n=37 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[low-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	SEL-212B (High-dose) n=38 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 during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (SEL-212A \[high-dose\]) for six additional doses, every 28 days, lasting up to approximately an additional six months.	Placebo n=37 participants at risk Participants received placebo (normal saline) via IV infusion every 28 days for approximately six months during the double-blind treatment phase. After completion of the double-blind treatment phase, participants continued into the double-blind extension phase. In this phase, participants continued in the identical study treatment group (placebo) for six additional doses, every 28 days, lasting up to approximately an additional six months.
Infections and infestations Pharyngitis streptococcal	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	62.2% 23/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	52.6% 20/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	62.2% 23/37 • Day 1 up to approximately 12 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 Hypertriglycerideaemia	8.1% 3/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	13.2% 5/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.7% 1/37 • Day 1 up to approximately 12 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	16.2% 6/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	13.2% 5/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.4% 2/37 • Day 1 up to approximately 12 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 Cellulitis	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	8.1% 3/37 • Day 1 up to approximately 12 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 Upper respiratory tract infection	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.7% 1/37 • Day 1 up to approximately 12 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 Folliculitis	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	10.8% 4/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	10.5% 4/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.4% 2/37 • Day 1 up to approximately 12 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 Ligament sprain	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.4% 2/37 • Day 1 up to approximately 12 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	10.8% 4/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	10.8% 4/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Vascular disorders Hypotension	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Gastrointestinal disorders Stomatitis	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	7.9% 3/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Gastrointestinal disorders Nausea	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Gastrointestinal disorders Mouth ulceration	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 Leukopenia	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.6% 1/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 Thrombocytopenia	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
General disorders Pyrexia	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	7.9% 3/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
General disorders Non-cardiac chest pain	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
General disorders Peripheral swelling	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Musculoskeletal and connective tissue disorders Gouty tophus	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	10.8% 4/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 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 Cough	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	2.7% 1/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Hepatobiliary disorders Hepatic steatosis	5.4% 2/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.
Investigations Blood pressure increased	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	5.3% 2/38 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.	0.00% 0/37 • Day 1 up to approximately 12 months Safety Set, which included all participants who were administered any amount of study drug. Participants were analyzed according to treatment received.