Trial Outcomes & Findings for Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis (NCT NCT02388737)

Last Updated: 2020-02-21

Results Overview

Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles \[LA\] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

703 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-02-21

Participant Flow

Participants took part in the study at 64 investigative sites in China, Malaysia, South Korea, and Taiwan from 01 April 2015 to 31 December 2018.

Participants with a diagnosis of erosive esophagitis were enrolled to receive lansoprazole 30 mg for 4 or 8 weeks (Healing Phase); or vonoprazan 10 mg, 20 mg; or lansoprazole 15 mg once daily for up to 24 weeks (Maintenance Phase).

Participant milestones

Participant milestones
Measure	Vonoprazan 10 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Overall Study STARTED	235	226	242
Overall Study COMPLETED	181	166	180
Overall Study NOT COMPLETED	54	60	62

Reasons for withdrawal

Reasons for withdrawal
Measure	Vonoprazan 10 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Overall Study Pretreatment Event/Adverse Event	13	11	12
Overall Study Major Protocol Deviation	18	25	22
Overall Study Lost to Follow-up	5	1	4
Overall Study Voluntary Withdrawal	10	18	17
Overall Study Lack of Efficacy	3	0	3
Overall Study Reason Not Specified	5	5	4

Baseline Characteristics

The number analyzed is the number of participants with data available for analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Total n=703 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 11.79 • n=235 Participants	52.8 years STANDARD_DEVIATION 13.02 • n=226 Participants	54.0 years STANDARD_DEVIATION 12.80 • n=242 Participants	52.8 years STANDARD_DEVIATION 12.56 • n=703 Participants
Sex: Female, Male Female	59 Participants n=235 Participants	61 Participants n=226 Participants	64 Participants n=242 Participants	184 Participants n=703 Participants
Sex: Female, Male Male	176 Participants n=235 Participants	165 Participants n=226 Participants	178 Participants n=242 Participants	519 Participants n=703 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=235 Participants	0 Participants n=226 Participants	0 Participants n=242 Participants	0 Participants n=703 Participants
Race (NIH/OMB) Asian	235 Participants n=235 Participants	225 Participants n=226 Participants	242 Participants n=242 Participants	702 Participants n=703 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=235 Participants	0 Participants n=226 Participants	0 Participants n=242 Participants	0 Participants n=703 Participants
Race (NIH/OMB) Black or African American	0 Participants n=235 Participants	0 Participants n=226 Participants	0 Participants n=242 Participants	0 Participants n=703 Participants
Race (NIH/OMB) White	0 Participants n=235 Participants	0 Participants n=226 Participants	0 Participants n=242 Participants	0 Participants n=703 Participants
Race (NIH/OMB) More than one race	0 Participants n=235 Participants	1 Participants n=226 Participants	0 Participants n=242 Participants	1 Participants n=703 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=235 Participants	0 Participants n=226 Participants	0 Participants n=242 Participants	0 Participants n=703 Participants
Region of Enrollment China	163 Participants n=235 Participants	159 Participants n=226 Participants	169 Participants n=242 Participants	491 Participants n=703 Participants
Region of Enrollment Malaysia	24 Participants n=235 Participants	24 Participants n=226 Participants	24 Participants n=242 Participants	72 Participants n=703 Participants
Region of Enrollment Korea, Republic Of	26 Participants n=235 Participants	23 Participants n=226 Participants	27 Participants n=242 Participants	76 Participants n=703 Participants
Region of Enrollment Taiwan, Province Of China	22 Participants n=235 Participants	20 Participants n=226 Participants	22 Participants n=242 Participants	64 Participants n=703 Participants
Height	166.7 centimeter (cm) STANDARD_DEVIATION 8.35 • n=235 Participants • The number analyzed is the number of participants with data available for analysis.	166.1 centimeter (cm) STANDARD_DEVIATION 8.31 • n=225 Participants • The number analyzed is the number of participants with data available for analysis.	167.1 centimeter (cm) STANDARD_DEVIATION 8.01 • n=241 Participants • The number analyzed is the number of participants with data available for analysis.	166.7 centimeter (cm) STANDARD_DEVIATION 8.22 • n=701 Participants • The number analyzed is the number of participants with data available for analysis.
Weight	70.03 kilogram (kg) STANDARD_DEVIATION 12.137 • n=235 Participants • The number analyzed is the number of participants with data available for analysis.	68.10 kilogram (kg) STANDARD_DEVIATION 11.314 • n=226 Participants • The number analyzed is the number of participants with data available for analysis.	69.19 kilogram (kg) STANDARD_DEVIATION 11.075 • n=240 Participants • The number analyzed is the number of participants with data available for analysis.	69.12 kilogram (kg) STANDARD_DEVIATION 11.528 • n=701 Participants • The number analyzed is the number of participants with data available for analysis.
Body Mass Index (BMI)	25.10 kg/m^2 STANDARD_DEVIATION 3.449 • n=235 Participants • The number analyzed is the number of participants with data available for analysis.	24.58 kg/m^2 STANDARD_DEVIATION 3.052 • n=225 Participants • The number analyzed is the number of participants with data available for analysis.	24.77 kg/m^2 STANDARD_DEVIATION 3.475 • n=239 Participants • The number analyzed is the number of participants with data available for analysis.	24.82 kg/m^2 STANDARD_DEVIATION 3.338 • n=699 Participants • The number analyzed is the number of participants with data available for analysis.
Smoking Classification The Participant Has Never Smoked	157 Participants n=235 Participants	135 Participants n=226 Participants	147 Participants n=242 Participants	439 Participants n=703 Participants
Smoking Classification The Participant Is a Current Smoker	50 Participants n=235 Participants	47 Participants n=226 Participants	55 Participants n=242 Participants	152 Participants n=703 Participants
Smoking Classification The Participant Is an Ex-smoker	28 Participants n=235 Participants	44 Participants n=226 Participants	40 Participants n=242 Participants	112 Participants n=703 Participants
Consumption of Alcohol Drink Everyday	11 Participants n=235 Participants	12 Participants n=226 Participants	16 Participants n=242 Participants	39 Participants n=703 Participants
Consumption of Alcohol Drink a Couple of Days Per Week	28 Participants n=235 Participants	19 Participants n=226 Participants	29 Participants n=242 Participants	76 Participants n=703 Participants
Consumption of Alcohol Drink a Couple of Days Per Month	53 Participants n=235 Participants	48 Participants n=226 Participants	41 Participants n=242 Participants	142 Participants n=703 Participants
Consumption of Alcohol Never Drink	143 Participants n=235 Participants	147 Participants n=226 Participants	156 Participants n=242 Participants	446 Participants n=703 Participants
Consumption of Caffeine Yes	37 Participants n=235 Participants	34 Participants n=226 Participants	43 Participants n=242 Participants	114 Participants n=703 Participants
Consumption of Caffeine No	198 Participants n=235 Participants	192 Participants n=226 Participants	199 Participants n=242 Participants	589 Participants n=703 Participants
History of H.pylori Eradication Therapy Yes (End of Treatment: Within Past 1 Year)	6 Participants n=235 Participants	9 Participants n=226 Participants	11 Participants n=242 Participants	26 Participants n=703 Participants
History of H.pylori Eradication Therapy Yes (End of Treatment: More than 1 Year)	20 Participants n=235 Participants	19 Participants n=226 Participants	16 Participants n=242 Participants	55 Participants n=703 Participants
History of H.pylori Eradication Therapy No	209 Participants n=235 Participants	198 Participants n=226 Participants	215 Participants n=242 Participants	622 Participants n=703 Participants
LA Classification (Time of Diagnosis) Grade A	91 Participants n=235 Participants	96 Participants n=226 Participants	93 Participants n=242 Participants	280 Participants n=703 Participants
LA Classification (Time of Diagnosis) Grade B	94 Participants n=235 Participants	84 Participants n=226 Participants	100 Participants n=242 Participants	278 Participants n=703 Participants
LA Classification (Time of Diagnosis) Grade C	42 Participants n=235 Participants	39 Participants n=226 Participants	38 Participants n=242 Participants	119 Participants n=703 Participants
LA Classification (Time of Diagnosis) Grade D	8 Participants n=235 Participants	7 Participants n=226 Participants	11 Participants n=242 Participants	26 Participants n=703 Participants
LA Classification (Time of Diagnosis) Grade A/B	185 Participants n=235 Participants	180 Participants n=226 Participants	193 Participants n=242 Participants	558 Participants n=703 Participants
LA Classification (Time of Diagnosis) Grade C/D	50 Participants n=235 Participants	46 Participants n=226 Participants	49 Participants n=242 Participants	145 Participants n=703 Participants
Barrett's Mucosa (Baseline) Present (3 cm or Greater)	3 Participants n=235 Participants	0 Participants n=226 Participants	3 Participants n=242 Participants	6 Participants n=703 Participants
Barrett's Mucosa (Baseline) Present (Less than 3 cm)	16 Participants n=235 Participants	24 Participants n=226 Participants	16 Participants n=242 Participants	56 Participants n=703 Participants
Barrett's Mucosa (Baseline) Absent	212 Participants n=235 Participants	197 Participants n=226 Participants	218 Participants n=242 Participants	627 Participants n=703 Participants
Barrett's Mucosa (Baseline) Unknown	4 Participants n=235 Participants	5 Participants n=226 Participants	4 Participants n=242 Participants	13 Participants n=703 Participants
Esophageal Hiatal Hernia (Baseline) Present (2 cm or Greater)	27 Participants n=235 Participants • The number analyzed is the number of participants with data available for analysis.	22 Participants n=226 Participants • The number analyzed is the number of participants with data available for analysis.	23 Participants n=241 Participants • The number analyzed is the number of participants with data available for analysis.	72 Participants n=702 Participants • The number analyzed is the number of participants with data available for analysis.
Esophageal Hiatal Hernia (Baseline) Present (Less than 2 cm)	30 Participants n=235 Participants • The number analyzed is the number of participants with data available for analysis.	22 Participants n=226 Participants • The number analyzed is the number of participants with data available for analysis.	29 Participants n=241 Participants • The number analyzed is the number of participants with data available for analysis.	81 Participants n=702 Participants • The number analyzed is the number of participants with data available for analysis.
Esophageal Hiatal Hernia (Baseline) Absent	174 Participants n=235 Participants • The number analyzed is the number of participants with data available for analysis.	179 Participants n=226 Participants • The number analyzed is the number of participants with data available for analysis.	184 Participants n=241 Participants • The number analyzed is the number of participants with data available for analysis.	537 Participants n=702 Participants • The number analyzed is the number of participants with data available for analysis.
Esophageal Hiatal Hernia (Baseline) Unknown	4 Participants n=235 Participants • The number analyzed is the number of participants with data available for analysis.	3 Participants n=226 Participants • The number analyzed is the number of participants with data available for analysis.	5 Participants n=241 Participants • The number analyzed is the number of participants with data available for analysis.	12 Participants n=702 Participants • The number analyzed is the number of participants with data available for analysis.
HRQoL (EQ-5D-5L)	0.9723 score on scale STANDARD_DEVIATION 0.04610 • n=226 Participants • The number analyzed is the number of participants with data available for analysis.	0.9723 score on scale STANDARD_DEVIATION 0.05252 • n=221 Participants • The number analyzed is the number of participants with data available for analysis.	0.9696 score on scale STANDARD_DEVIATION 0.06227 • n=235 Participants • The number analyzed is the number of participants with data available for analysis.	0.9713 score on scale STANDARD_DEVIATION 0.05410 • n=682 Participants • The number analyzed is the number of participants with data available for analysis.
EQ VAS Score (Baseline)	88.2 score on scale STANDARD_DEVIATION 11.10 • n=226 Participants • The number analyzed is the number of participants with data available for analysis.	89.3 score on scale STANDARD_DEVIATION 8.85 • n=221 Participants • The number analyzed is the number of participants with data available for analysis.	89.4 score on scale STANDARD_DEVIATION 9.03 • n=235 Participants • The number analyzed is the number of participants with data available for analysis.	89.0 score on scale STANDARD_DEVIATION 9.71 • n=682 Participants • The number analyzed is the number of participants with data available for analysis.

PRIMARY outcome

Timeframe: 24 weeks

Population: Full analysis set included all randomized participants who received at least 1 dose of the Maintenance Phase drug and had at least 1 post-baseline endoscopy, and was based on randomized treatment.

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase	13.3 percentage of participants Interval 8.684 to 19.084	12.3 percentage of participants Interval 7.765 to 18.158	25.5 percentage of participants Interval 19.412 to 32.481

SECONDARY outcome

Timeframe: 12 weeks

Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades A to D) during the Maintenance Phase (12 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference.

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase	27.8 percentage of participants Interval 9.695 to 53.48	10.0 percentage of participants Interval 1.235 to 31.698	35.0 percentage of participants Interval 15.391 to 59.219

SECONDARY outcome

Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Number of Participants With Adverse Events (AEs)	157 Participants	156 Participants	158 Participants

SECONDARY outcome

Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.

Clinical laboratory safety tests included chemistry, hematology and urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter.

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: Hematocrit (<0.8xLLN)	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: Red Blood Cells (>1.2xULN)	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: White Blood Cells (>1.5xULN)	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: Hemoglobin (<0.8xLLN)	1 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: Platelets (<75x10^9/L)	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: Neutrophils (<0.5xLLN)	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: Eosinophils (>2xULN)	2 Participants	2 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Hematology: Lymphocytes (>1.5xULN)	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: ALT (>3xULN)	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: AST (>3xULN)	2 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: GGT (>3xULN)	4 Participants	2 Participants	7 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: CK (CPK) (>5xULN)	4 Participants	2 Participants	3 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Albumin (<25 g/L)	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Creatinine (>177 umol/L)	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: BUN (>10.7 mmol/L)	2 Participants	4 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Uric Acid (>0.773 mmol/L)	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Total Cholesterol (>7.72 mmol/L)	2 Participants	5 Participants	3 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Triglycerides (>2.5xULN)	2 Participants	5 Participants	6 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Glucose (<2.8 mmol/L)	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Glucose (>19.4 mmol/L)	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Potassium (<3.0 mmol/L)	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Sodium (>150 mmol/L)	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Findings Serum Chemistry: Vitamin B12 (<92 pmol/L)	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline.

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Heart Rate (<50 bpm)	8 Participants	7 Participants	4 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Heart Rate (>120 bpm)	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings QT Interval (>=460 msec)	9 Participants	5 Participants	8 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings QTcF Interval (>= 500, or >= 450 with CHG >= 30)	8 Participants	3 Participants	6 Participants

SECONDARY outcome

Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

The percentage of participants with any markedly abnormal vital sign measurements including (body temperature, blood pressure and pulse), mmHg = millimeters of mercury.

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Number of Participants With Abnormal Vital Sign Measurements Body Temperature (<35.6 °Celsius)	6 Participants	3 Participants	12 Participants
Number of Participants With Abnormal Vital Sign Measurements Body Temperature (>37.7 °Celsius)	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Vital Sign Measurements Systolic Blood Pressure (<85 mmHg)	2 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Sign Measurements Diastolic Blood Pressure (<50 mmHg)	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Vital Sign Measurements Diastolic Blood Pressure (>110 mmHg)	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Sign Measurements Pulse (<50 bpm)	1 Participants	4 Participants	3 Participants
Number of Participants With Abnormal Vital Sign Measurements Pulse (>120 bpm)	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12 and 24

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Change From Baseline in Serum Gastrin Baseline	20.42 pmol/L Standard Deviation 33.969	17.97 pmol/L Standard Deviation 21.458	21.94 pmol/L Standard Deviation 27.905
Change From Baseline in Serum Gastrin Change at Week 4	10.09 pmol/L Standard Deviation 37.747	22.76 pmol/L Standard Deviation 36.053	-11.21 pmol/L Standard Deviation 24.651
Change From Baseline in Serum Gastrin Change at Week 12	14.45 pmol/L Standard Deviation 29.439	31.92 pmol/L Standard Deviation 45.127	-8.76 pmol/L Standard Deviation 24.578
Change From Baseline in Serum Gastrin Change at Week 24	17.47 pmol/L Standard Deviation 39.847	37.60 pmol/L Standard Deviation 47.172	-7.41 pmol/L Standard Deviation 22.210

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12 and 24

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Change From Baseline in Serum Pepsinogen I Change at Week 24	5.9 ug/L Standard Deviation 289.91	55.4 ug/L Standard Deviation 279.65	-103.9 ug/L Standard Deviation 218.80
Change From Baseline in Serum Pepsinogen I Baseline	287.1 ug/L Standard Deviation 249.41	276.3 ug/L Standard Deviation 203.46	303.3 ug/L Standard Deviation 253.76
Change From Baseline in Serum Pepsinogen I Change at Week 4	40.5 ug/L Standard Deviation 266.92	139.8 ug/L Standard Deviation 269.08	-112.3 ug/L Standard Deviation 245.22
Change From Baseline in Serum Pepsinogen I Change at Week 12	-3.1 ug/L Standard Deviation 267.65	89.9 ug/L Standard Deviation 285.05	-123.5 ug/L Standard Deviation 252.45

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12 and 24

Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase.The number analyzed is the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Vonoprazan 10 mg n=235 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 Participants Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Change From Baseline in Serum Pepsinogen II Baseline	22.9 ug/L Standard Deviation 22.42	22.1 ug/L Standard Deviation 17.40	24.6 ug/L Standard Deviation 23.83
Change From Baseline in Serum Pepsinogen II Change at Week 4	3.8 ug/L Standard Deviation 27.34	16.5 ug/L Standard Deviation 25.56	-10.9 ug/L Standard Deviation 23.98
Change From Baseline in Serum Pepsinogen II Change at Week 12	-1.6 ug/L Standard Deviation 24.02	9.0 ug/L Standard Deviation 26.40	-10.9 ug/L Standard Deviation 24.41
Change From Baseline in Serum Pepsinogen II Change at Week 24	-0.6 ug/L Standard Deviation 27.23	5.8 ug/L Standard Deviation 25.59	-8.7 ug/L Standard Deviation 19.61

Adverse Events

Vonoprazan 10 mg

Serious events: 10 serious events

Other events: 81 other events

Deaths: 0 deaths

Vonoprazan 20 mg

Serious events: 8 serious events

Other events: 79 other events

Deaths: 0 deaths

Lansoprazole 15 mg

Serious events: 12 serious events

Other events: 79 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Vonoprazan 10 mg n=235 participants at risk Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Vonoprazan 20 mg n=226 participants at risk Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.	Lansoprazole 15 mg n=242 participants at risk Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing.
Gastrointestinal disorders Diarrhoea	6.4% 15/235 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	9.3% 21/226 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.0% 17/242 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Dyspepsia	7.7% 18/235 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 10/226 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.0% 12/242 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Gastric polyps	4.7% 11/235 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.3% 12/226 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 8/242 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Abdominal distension	2.1% 5/235 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.7% 6/226 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.4% 13/242 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	12.8% 30/235 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.8% 29/226 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	8.7% 21/242 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Nasopharyngitis	5.1% 12/235 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.3% 12/226 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.5% 11/242 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Alanine aminotransferase increased	5.5% 13/235 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.0% 9/226 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.6% 16/242 • Up to 26 weeks At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: 877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER