Trial Outcomes & Findings for A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet (NCT NCT05353985)

Last Updated: 2025-08-20

Results Overview

CDSD GI symptom severity score is an average of the daily GI symptom severity scores during the week. The daily GI symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating and nausea, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as least squares (LS) mean change from baseline at Week 12, determined using a mixed-effect model for repeated measures (MMRM). A negative change from baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

153 participants

Primary outcome timeframe

Baseline (Week -1) to Week 12

Results posted on

2025-08-20

Participant Flow

Participants took part in the study at various investigative sites globally from 30 June 2022 to 06 November 2024.

Participants with a diagnosis of celiac disease were enrolled and randomly assigned to receive either TAK-062 Placebo + simulated inadvertent gluten exposure (SIGE) Gluten-Bar or pre-determined amount of TAK-062 + SIGE Gluten-Bar in Cohort 1. 153 participants were enrolled in the trial but 1 participant out of 153 was randomized but not treated. Cohort 2 of the trial was not initiated.

Participant milestones

Participant milestones
Measure	Placebo + SIGE Gluten-Bar Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Overall Study STARTED	76	77
Overall Study COMPLETED	55	51
Overall Study NOT COMPLETED	21	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo + SIGE Gluten-Bar Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Overall Study Adverse Event	5	7
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	13	17
Overall Study Reason Not Specified	1	0
Overall Study Randomized in Error & Not Treated	0	1

Baseline Characteristics

A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + SIGE Gluten-Bar n=76 Participants Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar n=77 Participants Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.	Total n=153 Participants Total of all reporting groups
Age, Continuous	45.2 years STANDARD_DEVIATION 15.35 • n=5 Participants	46.8 years STANDARD_DEVIATION 12.95 • n=7 Participants	46 years STANDARD_DEVIATION 14.16 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	58 Participants n=7 Participants	115 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants	70 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	71 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week -1) to Week 12

Population: The FAS-SIGE included all randomized participants who were randomized to receive gluten-containing SIGE. Overall number of participants analyzed is the number of participants with data available for analysis. Cohort 2 of the trial was not initiated.

Outcome measures

Outcome measures
Measure	Placebo + SIGE Gluten-Bar n=61 Participants Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar n=59 Participants Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12	-0.128 score on a scale Standard Error 0.083	-0.111 score on a scale Standard Error 0.082

SECONDARY outcome

Timeframe: Baseline (Week -4, Run-in Period) to Week 24

The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. Results are reported as least squares (LS) mean change from baseline at Week 24, determined using an analysis of covariance (ANCOVA) model. A negative change from baseline indicates worsening disease.

Outcome measures

Outcome measures
Measure	Placebo + SIGE Gluten-Bar n=60 Participants Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar n=59 Participants Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24	-0.006 unitless ratio Standard Error 0.100	-0.338 unitless ratio Standard Error 0.099

SECONDARY outcome

Timeframe: Up to Week 28

Population: The Safety Analysis Set (SAF) included all randomized participants who received at least 1 dose of study drug. Cohort 2 of the trial was not initiated.

Adverse event(AE)=any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have causal relationship with this treatment.AE can therefore be any unfavorable\&unintended sign(e.g.,clinically significant abnormal laboratory value, electrocardiogram\[ECG\] value,or vital sign measurement),symptom,or disease temporally associated with use of drug whether or not it is considered related to drug.TEAE=new onset or worsening AEs after first dose of study treatment regardless of relationship to study drug.SAE=any untoward medical occurrence at any dose that results in death,is life threatening,requires inpatient hospitalization/prolongation of existing hospitalization,results in persistent/significant disability/incapacity,leads to a congenital anomaly/birth defect/is important medical event. TEAEs considered related to study drug as assessed by investigator were reported.Percentages were rounded off to nearest single decimal place.

Outcome measures

Outcome measures
Measure	Placebo + SIGE Gluten-Bar n=76 Participants Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar n=76 Participants Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs TEAEs	64.5 percentage of participants	73.7 percentage of participants
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs Serious TEAEs	5.3 percentage of participants	1.3 percentage of participants
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs Treatment-Related TEAEs	5.3 percentage of participants	13.2 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 28

Population: Immunogenicity Analysis Set included all randomized participants who received any TAK-062 and had the baseline and at least 1 postbaseline immunogenicity sample assessment.

A positive ADA participant was defined as a participant who had at least 1 positive ADA result during the study and was further categorized as: Transiently positive- defined as participants with confirmed positive ADA in at least 1 sample and no consecutive samples; Persistently positive- defined as participants with confirmed positive ADA in 2 or more consecutive positive ADA samples.

Outcome measures

Outcome measures
Measure	Placebo + SIGE Gluten-Bar n=76 Participants Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar n=76 Participants Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062 At least 1 Positive ADA	27 Participants	67 Participants
Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062 Transiently Positive	19 Participants	8 Participants
Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062 Persistently Positive	8 Participants	59 Participants

Adverse Events

TAK-062 Placebo + SIGE Gluten-Bar

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

TAK-062 + SIGE Gluten-Bar

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TAK-062 Placebo + SIGE Gluten-Bar n=76 participants at risk Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar n=76 participants at risk Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Injury, poisoning and procedural complications ANASTOMOTIC COMPLICATION	1.3% 1/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	0.00% 0/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders ATRIAL FIBRILLATION	1.3% 1/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	0.00% 0/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	1.3% 1/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	0.00% 0/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Infections and infestations GASTROENTERITIS	1.3% 1/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	0.00% 0/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.00% 0/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	1.3% 1/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	TAK-062 Placebo + SIGE Gluten-Bar n=76 participants at risk Participants received TAK-062 placebo-matching tablets and SIGE gluten bar, orally for up to 24 weeks.	TAK-062 + SIGE Gluten-Bar n=76 participants at risk Participants received pre-determined amount of TAK-062 tablets and SIGE gluten bar, orally, for up to 24 weeks.
Gastrointestinal disorders ABDOMINAL DISTENSION	2.6% 2/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	5.3% 4/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL PAIN	3.9% 3/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	6.6% 5/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders DIARRHOEA	2.6% 2/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	17.1% 13/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
General disorders FATIGUE	3.9% 3/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	5.3% 4/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders GASTRITIS	0.00% 0/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	5.3% 4/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders NAUSEA	3.9% 3/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	5.3% 4/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Infections and infestations PHARYNGITIS STREPTOCOCCAL	2.6% 2/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	5.3% 4/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	2.6% 2/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	5.3% 4/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders VOMITING	3.9% 3/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.	5.3% 4/76 • Up to Week 28 The SAF included all randomized participants who received at least 1 dose of study drug.

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