Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis (NCT NCT02173301)

Last Updated: 2022-04-12

Results Overview

The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

12 Weeks

Results posted on

2022-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	XP23829 400 mg QD (Once Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control
Overall Study STARTED	49	55	48	48
Overall Study COMPLETED	29	32	28	33
Overall Study NOT COMPLETED	20	23	20	15

Reasons for withdrawal

Reasons for withdrawal
Measure	XP23829 400 mg QD (Once Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control
Overall Study Adverse Event	7	8	13	5
Overall Study Withdrawal by Subject	8	10	4	8
Overall Study Lost to Follow-up	4	4	2	2
Overall Study Protocol Violation	0	1	0	0
Overall Study Physician Decision	0	0	1	0
Overall Study Subject unable to return for week 16 assessment within Sponsor timelines for study completion	1	0	0	0

Baseline Characteristics

A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XP23829 400 mg QD (Once Daily) n=49 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) n=55 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) n=48 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo n=48 Participants After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control	Total n=200 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 11.89 • n=5 Participants	47.7 years STANDARD_DEVIATION 10.55 • n=7 Participants	51.8 years STANDARD_DEVIATION 13.80 • n=5 Participants	51.1 years STANDARD_DEVIATION 13.66 • n=4 Participants	50.3 years STANDARD_DEVIATION 12.49 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	23 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	70 Participants n=21 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	32 Participants n=7 Participants	32 Participants n=5 Participants	34 Participants n=4 Participants	130 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	1 Participants n=4 Participants	31 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	48 Participants n=7 Participants	37 Participants n=5 Participants	47 Participants n=4 Participants	169 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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 (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	48 Participants n=7 Participants	45 Participants n=5 Participants	44 Participants n=4 Participants	181 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (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
Baseline PASI score	18.32 units on a scale STANDARD_DEVIATION 7.413 • n=5 Participants	18.19 units on a scale STANDARD_DEVIATION 7.977 • n=7 Participants	17.51 units on a scale STANDARD_DEVIATION 4.791 • n=5 Participants	19.13 units on a scale STANDARD_DEVIATION 7.671 • n=4 Participants	18.28 units on a scale STANDARD_DEVIATION 7.082 • n=21 Participants
Baseline sPGA 3 Moderate	32 Participants n=5 Participants	39 Participants n=7 Participants	34 Participants n=5 Participants	34 Participants n=4 Participants	139 Participants n=21 Participants
Baseline sPGA 4 Severe	17 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	61 Participants n=21 Participants
Baseline Body Surface Area involved	22.90 percentage STANDARD_DEVIATION 13.324 • n=5 Participants	23.79 percentage STANDARD_DEVIATION 15.283 • n=7 Participants	23.08 percentage STANDARD_DEVIATION 14.585 • n=5 Participants	26.44 percentage STANDARD_DEVIATION 16.260 • n=4 Participants	24.04 percentage STANDARD_DEVIATION 14.860 • n=21 Participants
Has Used Systemic Biologics? No	32 Participants n=5 Participants	34 Participants n=7 Participants	30 Participants n=5 Participants	35 Participants n=4 Participants	131 Participants n=21 Participants
Has Used Systemic Biologics? Yes	17 Participants n=5 Participants	21 Participants n=7 Participants	18 Participants n=5 Participants	13 Participants n=4 Participants	69 Participants n=21 Participants
Body Weight	95.22 kilograms STANDARD_DEVIATION 25.710 • n=5 Participants	101.68 kilograms STANDARD_DEVIATION 26.142 • n=7 Participants	101.08 kilograms STANDARD_DEVIATION 27.207 • n=5 Participants	97.08 kilograms STANDARD_DEVIATION 25.136 • n=4 Participants	98.85 kilograms STANDARD_DEVIATION 26.007 • n=21 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: modified Intent-to-Treat population Observed cases analysis

Outcome measures

Outcome measures
Measure	XP23829 400 mg QD (Once Daily) n=48 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) n=53 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) n=46 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo n=47 Participants After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control
• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline	-38.1 percentage change from baseline Standard Error 5.07	-48.2 percentage change from baseline Standard Error 5.06	-50.7 percentage change from baseline Standard Error 5.50	-25.0 percentage change from baseline Standard Error 5.06

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 14 and 16

Population: modified Intent-to-treat population with last observation carried forward imputation for missing values

The percentage of subjects who achieve a reduction of 75% or greater from Baseline in the Psoriasis Area and Severity Index score (PASI-75) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.

Outcome measures

Outcome measures
Measure	XP23829 400 mg QD (Once Daily) n=48 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) n=53 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) n=46 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo n=47 Participants After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) Week 4	2 Participants	0 Participants	2 Participants	0 Participants
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) Week 12	6 Participants	7 Participants	10 Participants	4 Participants
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) Week 2	1 Participants	0 Participants	0 Participants	0 Participants
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) Week 8	3 Participants	2 Participants	5 Participants	2 Participants
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) Week 14	6 Participants	4 Participants	6 Participants	3 Participants
• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75) Week 16	3 Participants	3 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 14 and 16

Population: modified 'Intent-to-treat' population using Last Observation Carried Forward method to impute missing observations

The Percentage of subjects who achieve the static Physician's Global Assessment (sPGA) score of 'clear' or 'almost clear' (sPGA score 0 or 1) at efficacy assessments conducted at Weeks 2, 4, 8, 12, 14 and 16. Score Grade : Definition - 0 Clear: No signs of psoriasis 1. Almost clear: No thickening to minimal plaque elevation; Normal to slight pink coloration/faint erythema; Focal to minimal scaling 2. Mild: Slight elevation/thickening; Pink to light red coloration; Predominantly fine scaling partially or mostly covering lesions 3. Moderate: Clearly distinguishable/distinct thickening; Definite red coloration; Coarse scaling covering most plaques 4. Severe: Marked thickening with hard/sharp edges; Bright to deep dark red coloration; Thick/coarse scaling covering almost all or all lesions A lower score on this scale at the end of the study indicates an improvement in the disease condition.

Outcome measures

Outcome measures
Measure	XP23829 400 mg QD (Once Daily) n=48 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) n=53 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) n=46 Participants After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo n=47 Participants After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear Week 2	0 Participants	0 Participants	0 Participants	0 Participants
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear Week 4	1 Participants	1 Participants	0 Participants	0 Participants
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear Week 8	2 Participants	2 Participants	1 Participants	2 Participants
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear Week 12	5 Participants	3 Participants	3 Participants	2 Participants
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear Week 14	5 Participants	2 Participants	3 Participants	1 Participants
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear Week 16	5 Participants	1 Participants	4 Participants	1 Participants

Adverse Events

XP23829 400 mg QD (Once Daily)

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

XP23829 800 mg QD (Once Daily)

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

XP23829 400 mg BID (Twice Daily)

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	XP23829 400 mg QD (Once Daily) n=49 participants at risk After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) n=55 participants at risk After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) n=48 participants at risk After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo n=48 participants at risk After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control
Gastrointestinal disorders Abdominal Adhesions	2.0% 1/49 • Number of events 1 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Abdominal hernia	2.0% 1/49 • Number of events 1 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Small intestinal obstruction	2.0% 1/49 • Number of events 1 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Enterocolitis	0.00% 0/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	2.1% 1/48 • Number of events 1 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Hepatobiliary disorders Cholecystitis acute	0.00% 0/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	1.8% 1/55 • Number of events 1 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)

Other adverse events

Additional Information

Dr. Srinivas Shenoy B.,

Dr Reddy's Laboratories Ltd.

Phone: 49002900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication would have to be collaborative effort between Sponsor and Investigators
Publication restrictions are in place

Restriction type: OTHER

Measure	XP23829 400 mg QD (Once Daily) n=49 participants at risk After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period XP23829 400 mg QD: active dose 1	XP23829 800 mg QD (Once Daily) n=55 participants at risk After 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period XP 23829 800 mg QD: active dose 2	XP23829 400 mg BID (Twice Daily) n=48 participants at risk After 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period XP23829 400 mg BID: active dose 3	Placebo n=48 participants at risk After 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks Placebo: control
Gastrointestinal disorders Diarrhea	22.4% 11/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	40.0% 22/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	39.6% 19/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	14.6% 7/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Nausea	12.2% 6/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	7.3% 4/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	20.8% 10/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	12.5% 6/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Abdominal pain	2.0% 1/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	12.7% 7/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	22.9% 11/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Vascular disorders Flushing	8.2% 4/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	5.5% 3/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	6.2% 3/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Nervous system disorders Headache	4.1% 2/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	5.5% 3/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	10.4% 5/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Vomiting	6.1% 3/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	12.7% 7/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	2.1% 1/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	2.1% 1/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Abdominal pain upper	6.1% 3/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	3.6% 2/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	6.2% 3/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Flatulence	4.1% 2/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	9.1% 5/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	6.2% 3/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	2.0% 1/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	7.3% 4/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Skin and subcutaneous tissue disorders Pruritus	6.1% 3/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	3.6% 2/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	6.2% 3/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	2.1% 1/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Dyspepsia	4.1% 2/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	3.6% 2/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	6.2% 3/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	2.1% 1/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Musculoskeletal and connective tissue disorders Arthralgia	2.0% 1/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	5.5% 3/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	2.1% 1/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Constipation	4.1% 2/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	8.3% 4/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Blood and lymphatic system disorders Eosinophilia	0.00% 0/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	7.3% 4/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Gastrointestinal disorders Gastroesophageal reflux disease	6.1% 3/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	2.1% 1/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	4.2% 2/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)
Nervous system disorders Paraesthesia	0.00% 0/49 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	5.5% 3/55 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)	0.00% 0/48 • Baseline to Week 16 or study discontinuation Adverse Events are reported in the safety population ( which is identical to the randomized subject and intent-to treat populations)