Trial · NCT05353985
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
NCT05353985, Phase 2, Completed, Takeda; results first posted 2025-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet. Trials, record NCT05353985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05353985
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
- NCT number
- NCT05353985
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 153 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Celiac Disease
- Interventions
- TAK-062, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar, TAK-062 Placebo, Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
- First posted
- 2022-04-29
- Last updated
- 2025-08-20
- Other registries' IDs
- eudract:2020-005438-14
- Results first posted
- 2025-08-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12 | Baseline (Week -1) to Week 12 | 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. |
| Secondary | Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24 | 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. |
| Secondary | Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs | Up to Week 28 | 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. |
| Secondary | Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062 | Up to Week 28 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12 | Baseline (Week -1) to Week 12 | 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. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24 | Baseline (Week -4, Run-in Period) to Week 24 | 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. | unitless ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs | Up to Week 28 | 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. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Positive Antidrug Antibodies (ADA) in Serum for TAK-062 | Up to Week 28 | Immunogenicity Analysis Set included all randomized participants who received any TAK-062 and had the baseline and at least 1 postbaseline immunogenicity sample assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12 | Placebo + SIGE Gluten-Bar | -0.128 | Standard Error 0.083 | score on a scale | |
| Change in Weekly Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) Symptom Severity Score From Baseline to Week 12 | TAK-062 + SIGE Gluten-Bar | -0.111 | Standard Error 0.082 | score on a scale | |
| Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24 | Placebo + SIGE Gluten-Bar | -0.006 | Standard Error 0.100 | unitless ratio | |
| Change in Villous Height to Crypt Depth Ratio (Vh:Cd) From Baseline to Week 24 | TAK-062 + SIGE Gluten-Bar | -0.338 | Standard Error 0.099 | unitless ratio | |
| Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE), Serious Treatment-Emergent Adverse Events (Serious TEAEs) and Treatment-Related TEAEs | Placebo + SIGE Gluten-Bar | TEAEs | 64.5 | 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 | TAK-062 + SIGE Gluten-Bar | TEAEs | 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 | Placebo + SIGE Gluten-Bar | Serious TEAEs | 5.3 | 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 | TAK-062 + SIGE Gluten-Bar | Serious TEAEs | 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 | Placebo + SIGE Gluten-Bar | Treatment-Related TEAEs | 5.3 | 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 | TAK-062 + SIGE Gluten-Bar | Treatment-Related TEAEs | 13.2 | percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + SIGE Gluten-Bar | 76 | |
| Overall Study | STARTED | TAK-062 + SIGE Gluten-Bar | 77 | |
| Overall Study | COMPLETED | Placebo + SIGE Gluten-Bar | 55 | |
| Overall Study | COMPLETED | TAK-062 + SIGE Gluten-Bar | 51 | |
| Overall Study | NOT COMPLETED | Placebo + SIGE Gluten-Bar | 21 | |
| Overall Study | NOT COMPLETED | TAK-062 + SIGE Gluten-Bar | 26 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | TAK-062 Placebo + SIGE Gluten-Bar | 2 | 76 | |
| other | ABDOMINAL DISTENSION | Gastrointestinal disorders | TAK-062 + SIGE Gluten-Bar | 4 | 76 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | TAK-062 Placebo + SIGE Gluten-Bar | 3 | 76 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | TAK-062 + SIGE Gluten-Bar | 5 | 76 | |
| other | DIARRHOEA | Gastrointestinal disorders | TAK-062 Placebo + SIGE Gluten-Bar | 2 | 76 | |
| other | DIARRHOEA | Gastrointestinal disorders | TAK-062 + SIGE Gluten-Bar | 13 | 76 | |
| other | FATIGUE | General disorders | TAK-062 Placebo + SIGE Gluten-Bar | 3 | 76 | |
| other | FATIGUE | General disorders | TAK-062 + SIGE Gluten-Bar | 4 | 76 | |
| other | GASTRITIS | Gastrointestinal disorders | TAK-062 Placebo + SIGE Gluten-Bar | 0 | 76 | |
| other | GASTRITIS | Gastrointestinal disorders | TAK-062 + SIGE Gluten-Bar | 4 | 76 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAK-062 Placebo + SIGE Gluten-Bar | 0 | 76 |
| Total, all-cause mortality | TAK-062 + SIGE Gluten-Bar | 0 | 76 |
| Total, other adverse events | TAK-062 Placebo + SIGE Gluten-Bar | 13 | 76 |
| Total, other adverse events | TAK-062 + SIGE Gluten-Bar | 24 | 76 |
| Total, serious adverse events | TAK-062 Placebo + SIGE Gluten-Bar | 4 | 76 |
| Total, serious adverse events | TAK-062 + SIGE Gluten-Bar | 1 | 76 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAK-062 Placebo + SIGE Gluten-Bar vs TAK-062 + SIGE Gluten-Bar: deaths from any cause | Trial comparisons |
| TAK-062 Placebo + SIGE Gluten-Bar vs TAK-062 + SIGE Gluten-Bar: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05353985
GET https://conductscience.org/api/trials/v1/NCT05353985/events?page=2