Trial · NCT02637141
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
NCT02637141, Phase 2, Completed, Amgen; results first posted 2019-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease. Trials, record NCT02637141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02637141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
- NCT number
- NCT02637141
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Celiac Disease
- Interventions
- AMG 714, Placebo, Placebo Gluten Challenge, Gluten Challenge
- First posted
- 2015-12-22
- Last updated
- 2019-12-03
- Other registries' IDs
- eudract:2015-003647-19
- Results first posted
- 2019-12-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 | Baseline and week 12 | Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. |
| Secondary | Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 | Baseline and week 12 | Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes is associated with celiac disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. |
| Secondary | Number of Participants With Improvement in Marsh Score at Week 12 | Baseline and week 12 | The Marsh classification system describes the stages of damage in the small intestine as seen under a microscope, with possible values of 0, 1, 2, 3a, 3b, or 3c. A score of 0 (best score) indicates that the intestinal lining is normal and celiac disease highly unlikely, a score of 3c (worst score) indicates increased intraepithelial lymphocytes, increased crypt hyperplasia and complete villi atrophy. Improvement is defined as a lower grade on the Marsh score scale compared to baseline. |
| Secondary | Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12 | Baseline and week 12 | Levels of anti-tTG IgA antibodies in serum were determined using an enzyme-linked immunosorbent assay (ELISA) immunoassay. |
| Secondary | Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12 | Baseline and week 12 | Levels of serum anti-DGP antibodies (immunoglobulin A \[IgA\] and immunoglobulin G \[IgG\]) were determined using ELISA immunoassay. |
| Secondary | Number of Weekly Bowel Movements at Baseline and Week 12 | Baseline and week 12 | Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced on any given day, the participant was required to document this using the electronic diary. |
| Secondary | Number of Participants With Diarrhoea at Baseline and Week 12 | Baseline and week 12 | The Bristol Stool Form Scale (BSFS) is a pictorial aid to help study participants identify the shape and consistency of their bowel movements. Participants were asked to complete this form daily using an electronic diary at the time of each bowel movement. The BSFS categorizes bowel movements into 7 types, from Type 1 (separate hard lumps, like nuts; hard to pass) to Type 7 (watery, no solid pieces, entirely liquid). Diarrhoea was defined as at least one BSFS score \>= 6 for the given week. |
| Secondary | Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12 | Baseline and 12 weeks | The GSRS is a 15-question 7-scale questionnaire used to assess 5 dimensions of gastrointestinal syndromes: diarrhea, indigestion, constipation, abdominal pain, and reflux. Questions are scored between 1 (no discomfort at all) and 7 (very severe discomfort). The total GSRS score is calculated as the sum of the scores of all 15 questions, and ranges from 15 (no discomfort at all) to 105 (very severe discomfort in all 5 dimensions of gastrointestinal syndromes). |
| Secondary | Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12 | Baseline and 12 weeks | The CeD-GSRS score is derived from a subset of questions from the GSRS questionnaire, including the diarrhea, indigestion, and abdominal pain domains (a total of 10 questions), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort). The total CeD-GSRS score is calculated as the sum of the scores of all 10 questions, and ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 | Baseline and week 12 | The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 | Baseline and week 12 | The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Improvement in Marsh Score at Week 12 | Baseline and week 12 | The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12 | Baseline and week 12 | Per protocol 1 population with available data | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12 | Baseline and week 12 | Per protocol 1 population with available data | kU/L | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Weekly Bowel Movements at Baseline and Week 12 | Baseline and week 12 | Per protocol 1 population with available data | bowel movements per week | MEAN |
| SECONDARY | Number of Participants With Diarrhoea at Baseline and Week 12 | Baseline and week 12 | Per protocol 1 population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12 | Baseline and 12 weeks | Per protocol 1 population with available data | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12 | Baseline and 12 weeks | Per protocol 1 population with available data | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 | AMG 714 150 mg | -62.66 | Standard Error 5.39 | percent change | |
| Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 | AMG 714 300 mg | -53.78 | Standard Error 4.83 | percent change | |
| Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 | Placebo | -60.17 | Standard Error 5.22 | percent change | |
| Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 | AMG 714 150 mg | 95.14 | Standard Error 15.06 | percent change | |
| Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 | AMG 714 300 mg | 68.22 | Standard Error 13.64 | percent change | |
| Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 | Placebo | 109.46 | Standard Error 14.65 | percent change | |
| Number of Participants With Improvement in Marsh Score at Week 12 | AMG 714 150 mg | 0 | Participants | ||
| Number of Participants With Improvement in Marsh Score at Week 12 | AMG 714 300 mg | 0 | Participants | ||
| Number of Participants With Improvement in Marsh Score at Week 12 | Placebo | 0 | Participants | ||
| Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12 | AMG 714 150 mg | 5019.77 | Standard Error 1482.59 | percent change |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AMG 714 150 mg | 22 | |
| Overall Study | STARTED | AMG 714 300 mg | 22 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | Received Study Drug | AMG 714 150 mg | 22 | |
| Overall Study | Received Study Drug | AMG 714 300 mg | 21 | |
| Overall Study | Received Study Drug | Placebo | 19 | |
| Overall Study | COMPLETED | AMG 714 150 mg | 20 | |
| Overall Study | COMPLETED | AMG 714 300 mg | 20 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | AMG 714 150 mg | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events324
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 | Anaemia | Blood and lymphatic system disorders | 150 mg AMG 714 | 0 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | 300 mg AMG 714 | 0 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 19 | |
| other | Neutropenia | Blood and lymphatic system disorders | 150 mg AMG 714 | 1 | 22 | |
| other | Neutropenia | Blood and lymphatic system disorders | 300 mg AMG 714 | 0 | 21 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 0 | 19 | |
| other | Palpitations | Cardiac disorders | 150 mg AMG 714 | 0 | 22 | |
| other | Palpitations | Cardiac disorders | 300 mg AMG 714 | 0 | 21 | |
| other | Palpitations | Cardiac disorders | Placebo | 2 | 19 | |
| other | Ear pain | Ear and labyrinth disorders | 150 mg AMG 714 | 1 | 22 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 150 mg AMG 714 | 0 | 22 |
| Total, all-cause mortality | 300 mg AMG 714 | 0 | 21 |
| Total, all-cause mortality | Placebo | 0 | 19 |
| Total, other adverse events | 150 mg AMG 714 | 21 | 22 |
| Total, other adverse events | 300 mg AMG 714 | 20 | 21 |
| Total, other adverse events | Placebo | 19 | 19 |
| Total, serious adverse events | 150 mg AMG 714 | 0 | 22 |
| Total, serious adverse events | 300 mg AMG 714 | 0 | 21 |
| Total, serious adverse events | Placebo | 0 | 19 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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