Celiac DiseasePhase 2NCT02637141

A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

A Phase 2 study testing AMG 714 and Gluten Challenge in people with Celiac Disease, run by Amgen at 3 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Celiac Disease
What is being tested?: AMG 714 and Gluten Challenge
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 3 sitesFinland
Study dates: 13 Apr 2016to 14 Mar 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening
On a gluten-free diet for at least 12 months
Negative celiac serology
Avoidance of pregnancy

Who cannot join

Severe complications of celiac disease, such as refractory celiac disease
Celiac symptoms
Other concomitant autoimmune disease
Chronic, active gastrointestinal disease
Infections, concomitant diseases
Prohibited medications

Trial locations and contacts

3 sites in 1 country.

Finland3 sites

ODL
Oulu
Tampere University Hospital
Tampere
CRST
Turku

Other trials in Finland

About this study

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.

Conditions: Celiac Disease
Being tested: AMG 714, Placebo, Placebo Gluten Challenge, Gluten Challenge
Keywords: celiac, gluten, Interleukin 15 (IL-15), AMG 714, gluten challenge
Medical subject headings: Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 714Biological
Also called PRV-015
AMG 714 administered by subcutaneous injection
PlaceboBiological
Matching placebo to AMG 714 administered by subcutaneous injection
Placebo Gluten ChallengeOther
Gluten-free cookies (Finnish rusks)
Gluten ChallengeOther
Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving

Study groups in NCT02637141
Study group	Role	What they receive
AMG 714 150 mg	Experimental	Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). Receives: Biological: AMG 714; Other: Placebo Gluten Challenge; Other: Gluten Challenge
AMG 714 300 mg	Experimental	Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). Receives: Biological: AMG 714; Other: Placebo Gluten Challenge; Other: Gluten Challenge
Placebo	Placebo comparator	Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). Receives: Biological: Placebo; Other: Placebo Gluten Challenge; Other: Gluten Challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at 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.
Measured: Baseline and week 12

Secondary outcomes (8)

Percent Change From Baseline in Intraepithelial Lymphocyte Density at 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.
Measured: Baseline and week 12
Number of Participants With Improvement in Marsh Score at 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.
Measured: Baseline and week 12
Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12
Levels of anti-tTG IgA antibodies in serum were determined using an enzyme-linked immunosorbent assay (ELISA) immunoassay.
Measured: Baseline and week 12
Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12
Levels of serum anti-DGP antibodies (immunoglobulin A [IgA] and immunoglobulin G [IgG]) were determined using ELISA immunoassay.
Measured: Baseline and week 12
Number of Weekly Bowel Movements at 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.
Measured: Baseline and week 12
Number of Participants With Diarrhoea at 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.
Measured: Baseline and week 12
Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12
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).
Measured: Baseline and 12 weeks
Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12
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).
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 201614 Mar 2017

First posted22 Dec 2015 (estimated)
Study start13 Apr 2016
Primary completion15 Feb 2017
Study completion14 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Celiac DiseaseStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02637141
Sponsor's protocol ID: CELIM-NRCD-001
Other IDs: 2015-003647-19, 2015
Status last verified: Oct 2019
First submitted: 28 Nov 2015
Last updated: 3 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Publication in peer-reviewed journal

Publications

Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
PubMed 41039829
Lahdeaho ML, Scheinin M, Vuotikka P, Taavela J, Popp A, Laukkarinen J, Koffert J, Koivurova OP, Pesu M, Kivela L, Lovro Z, Keisala J, Isola J, Parnes JR, Leon F, Maki M. Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):948-959. doi: 10.1016/S2468-1253(19)30264-X. Epub 2019 Sep 4.
PubMed 31494096

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Celiac Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
ClinicalTrials.gov ID: NCT02637141
Acronym / sponsor ID: CELIM-NRCD-001
Conditions: Celiac Disease
Keywords: celiac, gluten, Interleukin 15 (IL-15), AMG 714, gluten challenge
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 13 Apr 2016 (actual)
Primary completion: 15 Feb 2017 (actual)
Study completion: 14 Mar 2017 (actual)
First posted: 22 Dec 2015 (estimated)
Results: Posted 3 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
AMG 714 150 mg	Experimental	Biological: AMG 714, Other: Placebo Gluten Challenge, Other: Gluten ChallengeParticipants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
AMG 714 300 mg	Experimental	Biological: AMG 714, Other: Placebo Gluten Challenge, Other: Gluten ChallengeParticipants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).
Placebo	Placebo comparator	Biological: Placebo, Other: Placebo Gluten Challenge, Other: Gluten ChallengeParticipants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening
On a gluten-free diet for at least 12 months
Negative celiac serology
Avoidance of pregnancy

Key exclusion criteria (6 listed)

Severe complications of celiac disease, such as refractory celiac disease
Celiac symptoms
Other concomitant autoimmune disease
Chronic, active gastrointestinal disease
Infections, concomitant diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMG 714Also: PRV-015AMG 714 administered by subcutaneous injection	Biological	AMG 714 150 mg, AMG 714 300 mg
PlaceboMatching placebo to AMG 714 administered by subcutaneous injection	Biological	Placebo
Placebo Gluten ChallengeGluten-free cookies (Finnish rusks)	Other	AMG 714 150 mg, AMG 714 300 mg, Placebo
Gluten ChallengeGluten-containing cookies (Finnish rusks), 1-2 g gluten per serving	Other	AMG 714 150 mg, AMG 714 300 mg, Placebo

Primary outcome

Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12
Time frame: 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.

8 secondary outcomes

Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12
Time frame: Baseline and week 12
Number of Participants With Improvement in Marsh Score at Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12
Time frame: Baseline and week 12
Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12
Time frame: Baseline and week 12
Number of Weekly Bowel Movements at Baseline and Week 12
Time frame: Baseline and week 12
Number of Participants With Diarrhoea at Baseline and Week 12
Time frame: Baseline and week 12
Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12
Time frame: Baseline and 12 weeks
Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 3 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AMG 714 150 mg	22	20
AMG 714 300 mg	22	20
Placebo	20	19

Primary outcome: Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12

Time frame: Baseline and week 12. Least squares mean (Standard Error). Unit: percent change

Measure	AMG 714 150 mg n = 15	AMG 714 300 mg n = 19	Placebo n = 15
Value	-62.66 (5.39)	-53.78 (4.83)	-60.17 (5.22)

AMG 714 150 mg vs Placebo: LS Mean Difference: -2.49 (95% CI -16.82 to 11.83), p = 0.7271, ANCOVA
AMG 714 300 mg vs Placebo: LS Mean Difference: 6.39 (95% CI -7.07 to 19.85), p = 0.3438, ANCOVA

Population analysed: 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.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug until week 16. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
150 mg AMG 714	0 of 22 (0%)	21 of 22 (95.5%)	0 of 22
300 mg AMG 714	0 of 21 (0%)	20 of 21 (95.2%)	0 of 21
Placebo	0 of 19 (0%)	19 of 19 (100%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41039829Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
Derived from this study: PubMed 31494096Lahdeaho ML, Scheinin M, Vuotikka P, Taavela J, Popp A, Laukkarinen J, Koffert J, Koivurova OP, Pesu M, Kivela L, Lovro Z, Keisala J, Isola J, Parnes JR, Leon F, Maki M. Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):948-959. doi: 10.1016/S2468-1253(19)30264-X. Epub 2019 Sep 4.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Publication in peer-reviewed journal

Related trials for Celiac Disease

Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
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Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amgen, MD study director

Amgen

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 714 and Gluten Challenge in people with Celiac Disease, run by Amgen at 3 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02637141, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.