Celiac DiseasePhase 1NCT04524221
PTG-100 for Patients With Celiac Disease
A Phase 1 study testing PTG-100 in people with Celiac Disease, run by Nielsen Fernandez-Becker at 1 site in United States.
Trial summary
The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- PTG-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 3 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of celiac disease
Who cannot join
- Active GI disease or history of clinically significant diseases
- Diagnosis of Crohn's disease or ulcerative colitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Study of PTG-100 in Patients With Celiac Disease
The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten.
This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.
- Conditions
- Celiac Disease
- Being tested
- PTG-100, Placebo
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTG-100Drug
PTG-100, 600mg taken twice daily in capsule form for 42 days
PlaceboDrug
Placebo taken twice daily in capsule form for 42 days
| Study group | Role | What they receive |
|---|---|---|
| PTG-100 | Experimental | Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. Receives: Drug: PTG-100 |
| Placebo | Placebo comparator | Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in villous height-to crypt ratio
Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio
Measured: 42 days
Secondary outcomes (5)
Change in celiac disease antibodies
Changes in anti-tTG antibodies from baseline
Measured: 42 days
Changes in celiac disease antibodies
Changes in anti-DGP antibodies from baseline
Measured: 42 days
CD3- positive intraepithelial lymphocyte density
CD3- positive intraepithelial lymphocyte density
Measured: 42 days
Celiac symptom index (CSI)
Changes in validated celiac symptom index (CSI)
Measured: 42 days
Characterization of immune modulators underlying mechanism of action in celiac disease.
Identification of immune cell populations targeted by PTG-100 to better understand mechanism of action in celiac disease in both blood and tissue temporally following exposure to drug.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start26 Feb 2021
- Primary completion3 Apr 2022
- Study completion3 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nielsen Fernandez-Becker
- Sponsor type
- University, hospital or other
- Collaborators
- Protagonist Therapeutics, Inc.
- Responsible party
- Sponsor-investigator, Nielsen Fernandez-Becker, Stanford University
- Investigators
- Nielsen Q Fernandez-Becker, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524221
- Sponsor's protocol ID
- 57613
- Other IDs
- PTG-100-05-CeD
- Status last verified
- May 2022
- First submitted
- 19 Aug 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of PTG-100 in Patients With Celiac Disease
- ClinicalTrials.gov ID
- NCT04524221
- Acronym / sponsor ID
- 57613
- Conditions
- Celiac Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nielsen Fernandez-BeckerUniversity, hospital or other
- Collaborators
- Protagonist Therapeutics, Inc.
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 3 Apr 2022 (actual)
- Study completion
- 3 Apr 2022 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten.
This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| PTG-100 | Experimental | Drug: PTG-100Patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of celiac disease
Key exclusion criteria (2 listed)
- Active GI disease or history of clinically significant diseases
- Diagnosis of Crohn's disease or ulcerative colitis.
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 |
|---|---|---|
| PTG-100PTG-100, 600mg taken twice daily in capsule form for 42 days | Drug | PTG-100 |
| PlaceboPlacebo taken twice daily in capsule form for 42 days | Drug | Placebo |
Primary outcome
Percentage change in villous height-to crypt ratio
Time frame: 42 days
Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio
5 secondary outcomes
Change in celiac disease antibodies
Time frame: 42 days
Changes in celiac disease antibodies
Time frame: 42 days
CD3- positive intraepithelial lymphocyte density
Time frame: 42 days
Celiac symptom index (CSI)
Time frame: 42 days
Characterization of immune modulators underlying mechanism of action in celiac disease.
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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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.
Nielsen Q Fernandez-Becker, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PTG-100 in people with Celiac Disease, run by Nielsen Fernandez-Becker at 1 site in United States.
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 1 inclusion and 2 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage change in villous height-to crypt ratio (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.