Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease (NCT NCT02177786)

Last Updated: 2019-11-05

Results Overview

The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 × age\^-0.203 × 1.212 (if participant is black) × 0.742 (if female).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

334 participants

Primary outcome timeframe

Baseline; Week 48

Results posted on

2019-11-05

Participant Flow

Participants were enrolled at study sites in United States and Canada. The first participant was screened on 30 June 2014. The last study visit occurred on 22 August 2016.

893 participants were screened.

Participant milestones

Participant milestones
Measure	Selonsertib 2 mg Selonsertib 2 mg tablet once daily for 48 weeks	Selonsertib 6 mg Selonsertib 6 mg tablet once daily for 48 weeks	Selonsertib 18 mg Selonsertib 18 mg tablet once daily for 48 weeks	Placebo Placebo tablet once daily for 48 weeks
Overall Study STARTED	81	84	84	85
Overall Study Randomized and Treated	81	84	83	85
Overall Study COMPLETED	75	70	66	72
Overall Study NOT COMPLETED	6	14	18	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Selonsertib 2 mg Selonsertib 2 mg tablet once daily for 48 weeks	Selonsertib 6 mg Selonsertib 6 mg tablet once daily for 48 weeks	Selonsertib 18 mg Selonsertib 18 mg tablet once daily for 48 weeks	Placebo Placebo tablet once daily for 48 weeks
Overall Study Withdrew Consent	2	6	9	5
Overall Study Progression to End Stage Renal Disease	2	3	2	1
Overall Study Adverse Event	1	1	2	3
Overall Study Death	1	1	1	1
Overall Study Lost to Follow-up	0	0	2	2
Overall Study Non-Compliance with Study Drug	0	1	0	1
Overall Study Protocol Violation	0	0	2	0
Overall Study Progressive Disease	0	1	0	0
Overall Study Missing study completion status	0	1	0	0

Baseline Characteristics

Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selonsertib 2 mg n=81 Participants Selonsertib 2 mg tablet once daily for 48 weeks	Selonsertib 6 mg n=84 Participants Selonsertib 6 mg tablet once daily for 48 weeks	Selonsertib 18 mg n=83 Participants Selonsertib 18 mg tablet once daily for 48 weeks	Placebo n=85 Participants Placebo tablet once daily for 48 weeks	Total n=333 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 8.1 • n=5 Participants	62 years STANDARD_DEVIATION 8.1 • n=7 Participants	63 years STANDARD_DEVIATION 9.0 • n=5 Participants	62 years STANDARD_DEVIATION 7.9 • n=4 Participants	63 years STANDARD_DEVIATION 8.3 • n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	20 Participants n=7 Participants	27 Participants n=5 Participants	32 Participants n=4 Participants	107 Participants n=21 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	64 Participants n=7 Participants	56 Participants n=5 Participants	53 Participants n=4 Participants	226 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	31 Participants n=7 Participants	33 Participants n=5 Participants	30 Participants n=4 Participants	119 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	53 Participants n=7 Participants	50 Participants n=5 Participants	55 Participants n=4 Participants	214 Participants n=21 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	0 Participants n=21 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black	20 Participants n=5 Participants	23 Participants n=7 Participants	11 Participants n=5 Participants	19 Participants n=4 Participants	73 Participants n=21 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	53 Participants n=5 Participants	57 Participants n=7 Participants	68 Participants n=5 Participants	61 Participants n=4 Participants	239 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	4 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Region of Enrollment United States	79 Participants n=5 Participants	81 Participants n=7 Participants	80 Participants n=5 Participants	81 Participants n=4 Participants	321 Participants n=21 Participants
Estimated Glomerular Filtration Rate (eGFR)	31.6 mL/min/1.73 m^2 STANDARD_DEVIATION 10.92 • n=5 Participants	31.9 mL/min/1.73 m^2 STANDARD_DEVIATION 11.58 • n=7 Participants	31.1 mL/min/1.73 m^2 STANDARD_DEVIATION 10.44 • n=5 Participants	31.4 mL/min/1.73 m^2 STANDARD_DEVIATION 11.87 • n=4 Participants	31.5 mL/min/1.73 m^2 STANDARD_DEVIATION 11.18 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline; Week 48

Population: Full Analysis Set included all randomized participants who took at least 1 dose of study drug.

The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine\^-1.154 × age\^-0.203 × 1.212 (if participant is black) × 0.742 (if female).

Outcome measures

Outcome measures
Measure	Selonsertib 2 mg n=81 Participants Selonsertib 2 mg tablet once daily for 48 weeks	Selonsertib 6 mg n=84 Participants Selonsertib 6 mg tablet once daily for 48 weeks	Selonsertib 18 mg n=83 Participants Selonsertib 18 mg tablet once daily for 48 weeks	Placebo n=85 Participants Placebo tablet once daily for 48 weeks
Change in eGFR From Baseline at Week 48	-2.83 mL/min/1.73 m^2 Standard Error 0.86	-2.37 mL/min/1.73 m^2 Standard Error 0.87	-4.07 mL/min/1.73 m^2 Standard Error 0.89	-3.20 mL/min/1.73 m^2 Standard Error 0.85

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Full Analysis Set were analyzed.

Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.

Outcome measures

Outcome measures
Measure	Selonsertib 2 mg n=81 Participants Selonsertib 2 mg tablet once daily for 48 weeks	Selonsertib 6 mg n=84 Participants Selonsertib 6 mg tablet once daily for 48 weeks	Selonsertib 18 mg n=83 Participants Selonsertib 18 mg tablet once daily for 48 weeks	Placebo n=85 Participants Placebo tablet once daily for 48 weeks
Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48	28.4 percentage of participants	21.4 percentage of participants	27.7 percentage of participants	30.6 percentage of participants

Adverse Events

Selonsertib 2 mg

Serious events: 24 serious events

Other events: 51 other events

Deaths: 0 deaths

Selonsertib 6 mg

Serious events: 20 serious events

Other events: 47 other events

Deaths: 0 deaths

Selonsertib 18 mg

Serious events: 20 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo

Serious events: 16 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER

Measure	Selonsertib 2 mg n=81 participants at risk Selonsertib 2 mg tablet once daily for 48 weeks	Selonsertib 6 mg n=84 participants at risk Selonsertib 6 mg tablet once daily for 48 weeks	Selonsertib 18 mg n=83 participants at risk Selonsertib 18 mg tablet once daily for 48 weeks	Placebo n=85 participants at risk Placebo tablet once daily for 48 weeks
Blood and lymphatic system disorders Anaemia	3.7% 3/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.7% 4/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	0.00% 0/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Gastrointestinal disorders Constipation	7.4% 6/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	8.3% 7/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	2.4% 2/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	8.6% 7/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	2.4% 2/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	8.4% 7/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.7% 4/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Gastrointestinal disorders Nausea	9.9% 8/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.8% 4/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.7% 4/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
General disorders Oedema peripheral	2.5% 2/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.8% 4/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	8.2% 7/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Bronchitis	1.2% 1/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	5.9% 5/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Cellulitis	1.2% 1/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	7.2% 6/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	0.00% 0/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	6.2% 5/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	9.6% 8/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	9.4% 8/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Infections and infestations Urinary tract infection	6.2% 5/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.7% 4/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Investigations Blood creatinine increased	7.4% 6/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	2.4% 2/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Gout	3.7% 3/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	0.00% 0/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	6.2% 5/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	7.4% 6/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	8.4% 7/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.7% 4/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	7.4% 6/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.8% 4/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.8% 4/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	3.7% 3/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	2.4% 2/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 6/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	5.9% 5/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	3.7% 3/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	7.1% 6/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	7.2% 6/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	2.4% 2/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Nervous system disorders Dizziness	1.2% 1/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	1.2% 1/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.7% 4/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	1.2% 1/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	4.8% 4/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	0.00% 0/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Renal and urinary disorders Chronic kidney disease	2.5% 2/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.5% 3/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Renal and urinary disorders End stage renal disease	2.5% 2/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	5.9% 5/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 3/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	2.4% 2/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	6.0% 5/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	0.00% 0/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 1/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.6% 3/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	7.2% 6/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	3.5% 3/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.
Vascular disorders Hypertension	8.6% 7/81 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	7.1% 6/84 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	2.4% 2/83 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.	7.1% 6/85 • First dose date up to Week 48 plus 30 days Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.