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Could a simple infusion let celiac patients eat gluten again?

NCT ID NCT05660109

Disease control Sponsor: Topas Therapeutics GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called TPM502 in 28 adults with celiac disease. The goal was to see if two infusions of TPM502 could safely train the immune system to tolerate gluten, potentially reducing the need for a lifelong gluten-free diet. Participants received either TPM502 or a placebo and underwent gluten challenges to measure immune responses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TPM502 (a mixture of gluten protein fragments designed to train the immune system to tolerate gluten)
What this could lead to
If it works, this could point toward a treatment that allows people with celiac disease to eat gluten without harm, reducing the need for a strict gluten-free diet.
What could go wrong
This is a small, early-phase trial (28 people) focused on safety and immune markers, not on actual symptom relief. The treatment may not produce meaningful tolerance, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

28 people

The number who actually took part.

Started

Dec 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissue transglutaminase \>10x ULN and documented positive IgA anti-endomysial antibody (EMA) at time of CeD diagnosis (as per local guidelines) * Serum anti-tissue transglutaminase 2 immunoglobin A antibodies within normal range (i.e., \<15 U/mL) at screening * Serum IL-2 levels (AUC1-6h) above a pre-defined threshold following the GC at screening * Patients must have been on GFD for ≥ 6 months * Patients must have well-controlled CeD, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD, as per investigator's assessment * HLA-DQ2.5 positive Exclusion Criteria: * Known or suspected refractory CeD (refractory CeD type I or II) * Known intolerable symptoms following previous GCs, as per investigator's assessment * HLA DQ8 positive * Any active gastrointestinal disease such as gastroesophageal reflux disease, esophagitis or peptic ulcer, microscopic colitis, or irritable bowel syndrome, which in the opinion of the investigator might interfere with the assessment of the symptoms related to CeD * Known history of or active Crohn's disease, ulcerative colitis, or ulcerative jejunitis * Known wheat allergy * Known hypersensitivity to i.v. iron preparations or any other excipients present in the reconstituted TPM502 or placebo

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Conditions

The condition(s) this trial relates to.

celiac disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

Contacts and locations

Locations

  • CRST Oy

    Turku, FI-20520, Finland

  • Centre for Human Drug Research

    Leiden, 2333 ZA, Netherlands

  • Charite' Hospital

    Berlin, 12200, Germany

  • Clinical Trial Consultants, Uppsala University

    Uppsala, 752 37, Sweden

  • Oslo University Hospital HF - Rikshospitalet

    Oslo, 0372, Norway

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • University Hospital of North-Norway

    Tromsø, 9038, Norway

  • Wesley Research Institute

    Brisbane, 4066, Australia

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