Trial Outcomes & Findings for A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS) (NCT NCT05543174)

Last Updated: 2026-01-29

Results Overview

Change in fasting sBA levels from Week 18 to 22 was reported. Change was calculated as: observed value at Week 22- observed value at Week 18.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

7 participants

Primary outcome timeframe

From Week 18 to Week 22

Results posted on

2026-01-29

Participant Flow

Participants took part in the study at 8 sites in Japan.

Participants diagnosed with Alagille Syndrome (ALGS) were enrolled to receive TAK-625 once daily (QD). The study consisted of the screening period, 2-week dose escalation period, 46-week stable dosing period, a follow-up dosing period after Week 48, and a safety follow-up period.

Participant milestones

Participant milestones
Measure	TAK-625 Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 micrograms per kilograms (mcg/kg) and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Overall Study STARTED	7
Overall Study Dosed TAK-625 200 mcg/kg	7
Overall Study Dosed TAK-625 400 mcg/kg	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TAK-625 Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 micrograms per kilograms (mcg/kg) and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Overall Study Adverse Event	1

Baseline Characteristics

A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Age, Continuous	6.143 years STANDARD_DEVIATION 3.8675 • n=35 Participants
Sex: Female, Male Female	2 Participants n=35 Participants
Sex: Female, Male Male	5 Participants n=35 Participants
Race/Ethnicity, Customized Asian	7 Participants n=35 Participants

PRIMARY outcome

Timeframe: From Week 18 to Week 22

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

Change in fasting sBA levels from Week 18 to 22 was reported. Change was calculated as: observed value at Week 22- observed value at Week 18.

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Fasting Serum Bile Acid (sBA) Levels From Week 18 to Week 22	17.643 micromoles per liter (mcmol/L) Interval -31.6389 to 66.9246

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

Change in fasting sBA levels from baseline to Week 18 was reported. Change was calculated as: observed value at Week 18 - observed value at baseline (before dosing).

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Fasting sBA Levels From Baseline to Week 18	8.300 mcmol/L Interval -37.411 to 54.011

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average severity of Pruritus is calculated based on daily maximum of morning and evening severity scores measured by ItchRO (Obs). Weekly average severity was calculated as the average of the daily maximum of morning and evening over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1).

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18	-1.531 score on a scale Interval -2.3405 to -0.7208

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average morning severity was calculated as the average of the daily morning scores over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1).

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Morning Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18	-1.327 score on a scale Interval -2.1071 to -0.546

SECONDARY outcome

Timeframe: From Week 18 to Week 22

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average severity of Pruritus was calculated based on daily maximum of morning and evening severity scores measured by ItchRO (Obs). Weekly average severity were calculated as the average of the daily maximum of morning and evening over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 22 (Day 148 to Day 154) - average value of Week 18 (Day 120 to Day 126).

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22	-0.286 score on a scale Interval -0.6594 to 0.088

SECONDARY outcome

Timeframe: From Week 18 to Week 22

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average morning severity was calculated as the average of the daily morning scores over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 22 (Day 148 to Day 154) - average value of Week 18 (Day 120 to Day 126).

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22	-0.280 score on a scale Interval -0.6769 to 0.1163

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure.

The ItchRO (Pt) scale measures severity of pruritus. The score on ItchRO (Pt) scale ranged from 0 to 4, where 0= Not felt itchy, 1= Felt a little bit itchy, 2= Felt pretty itchy, 3= Felt very itchy, 4= Felt very, very itchy. A higher score indicated more severe pruritus. Weekly average severity of Pruritus was calculated based on daily maximum of morning and evening severity scores measured by ItchRO (Pt). Weekly average scores was calculated as the average of the daily maximum of morning and evening over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1).

Outcome measures

Outcome measures
Measure	TAK-625 n=3 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18	-1.381 score on a scale Interval -5.0058 to 2.2439

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITT included all participants who received at least one dose of study drug. Here, "overall number of participants analyzed" signified those participants who were evaluable for this outcome measure. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

The ItchRO (Pt) scale measures severity of pruritus. The score on ItchRO (Pt) scale ranged from 0 to 4, where 0= Not felt itchy, 1= Felt a little bit itchy, 2= Felt pretty itchy, 3= Felt very itchy, 4= Felt very, very itchy. A higher score indicated more severe pruritus. Weekly average morning severity was calculated as the average of the daily morning scores over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1).

Outcome measures

Outcome measures
Measure	TAK-625 n=3 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18	-1.238 score on a scale Interval -3.6537 to 1.1775

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

Change in ALT and ALP levels from baseline to Week 18 were reported. Change was calculated as: observed value at Week 18 - observed value at baseline (before dosing).

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels From Baseline to Week 18 Change in ALT	17.7 Units per liter (U/L) Interval -52.66 to 88.09
Change in Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels From Baseline to Week 18 Change in ALP	75.6 Units per liter (U/L) Interval -186.5 to 337.64

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

Change in bilirubin (total and direct) from baseline to Week 18 was reported. Change was calculated as: observed value at Week 18 - observed value at baseline (before dosing).

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Bilirubin (Total and Direct) Levels From Baseline to Week 18 Change in total bilirubin	11.3619 mcmol/L Interval -20.13472 to 42.85861
Change in Bilirubin (Total and Direct) Levels From Baseline to Week 18 Change in direct bilirubin	8.6009 mcmol/L Interval -15.59872 to 32.80046

SECONDARY outcome

Timeframe: From Week 18 to 22

The ItchRO (Pt) scale measures severity of pruritus. The score on ItchRO (Pt) scale ranged from 0 to 4, where 0= Not felt itchy, 1= Felt a little bit itchy, 2= Felt pretty itchy, 3= Felt very itchy, 4= Felt very, very itchy. A higher score indicated more severe pruritus. Weekly average severity of Pruritus was calculated based on daily maximum of morning and evening severity scores measured by ItchRO (Pt). Weekly average scores was calculated as the average of the daily maximum of morning and evening over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 22 (Day 148 to Day 154) - average value of Week 18 (Day 120 to Day 126).

Outcome measures

Outcome measures
Measure	TAK-625 n=3 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Severity of Pruritus Measured by ItchRO (Pt) From Week 18 to Week 22	0.000 score on a scale Interval -0.6147 to 0.6147

SECONDARY outcome

Timeframe: From Week 18 to 22

The ItchRO (Pt) scale measures severity of pruritus. The score on ItchRO (Pt) scale ranged from 0 to 4, where 0= Not felt itchy, 1= Felt a little bit itchy, 2= Felt pretty itchy, 3= Felt very itchy, 4= Felt very, very itchy. A higher score indicated more severe pruritus. Weekly average morning severity was calculated as the average of the daily morning scores over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 22 (Day 148 to Day 154) - average value of Week 18 (Day 120 to Day 126).

Outcome measures

Outcome measures
Measure	TAK-625 n=3 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Pt) From Week 18 to Week 22	-0.032 score on a scale Interval -0.412 to 0.3485

SECONDARY outcome

Timeframe: From Week 18 to 22

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

Change in ALT and ALP from Week 18 to 22 was reported. Change was calculated as: observed value at Week 22 - observed value at Week 18.

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in ALT and ALP Levels From Week 18 to 22 Change in ALT	7.9 U/L Interval -22.18 to 37.89
Change in ALT and ALP Levels From Week 18 to 22 Change in ALP	-32.3 U/L Interval -79.12 to 14.55

SECONDARY outcome

Timeframe: From Week 18 to 22

Population: ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort.

Change in bilirubin (total and direct) from Week 18 to 22 was reported. Change was calculated as: observed value at Week 22 - observed value at Week 18.

Outcome measures

Outcome measures
Measure	TAK-625 n=7 Participants Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Change in Bilirubin (Total and Direct) Levels From Week 18 to 22 Change in total bilirubin	0.6842 mcmol/L Interval -4.6058 to 5.97412
Change in Bilirubin (Total and Direct) Levels From Week 18 to 22 Change in direct bilirubin	1.2217 mcmol/L Interval -1.83803 to 4.28146

Adverse Events

TAK-625

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TAK-625 n=7 participants at risk Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
Surgical and medical procedures Liver transplant	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Metabolism and nutrition disorders Malnutrition	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Metabolism and nutrition disorders Weight gain poor	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.

Other adverse events

Other adverse events
Measure	TAK-625 n=7 participants at risk Participants diagnosed with ALGS received TAK-625 orally, QD. In dose escalation period, dose was increased weekly, 200 mcg/kg and 400 mcg/kg for up to 2 weeks. After the dose escalation period, each participant continued dosing with TAK-625 400 mcg/kg, orally, QD dose level in the stable dosing period for 46 weeks and a follow-up dosing period after Week 48, followed by a safety follow-up period.
General disorders Administration site extravasation	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Investigations Alanine aminotransferase increased	28.6% 2/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Gastrointestinal disorders Anal rash	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Injury, poisoning and procedural complications Arthropod bite	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations COVID-19	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Gastrointestinal disorders Chapped lips	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Congenital, familial and genetic disorders Congenital arterial malformation	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Gastrointestinal disorders Defaecation urgency	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Skin and subcutaneous tissue disorders Dermatitis atopic	28.6% 2/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Skin and subcutaneous tissue disorders Dermatitis diaper	28.6% 2/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Injury, poisoning and procedural complications Eyelid injury	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Gastroenteritis	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Hand-foot-and-mouth disease	28.6% 2/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Metabolism and nutrition disorders Hypercholesterolaemia	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Influenza	57.1% 4/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Nasopharyngitis	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Eye disorders Ocular hyperaemia	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Otitis externa	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Otitis media	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Rhinitis	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Injury, poisoning and procedural complications Skin abrasion	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Injury, poisoning and procedural complications Upper limb fracture	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Infections and infestations Upper respiratory tract infection	42.9% 3/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	28.6% 2/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.
Gastrointestinal disorders Vomiting	14.3% 1/7 • From the first dose of study drug up to Week 133 As per-planned analysis, the data for adverse events section were collected, analyzed and reported as a single cohort.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER