A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

Study Purpose

The goal of this clinical trial is to learn about the safety and the pharmacodynamic (PD) effects of TPM502 in adults with celiac disease. The main questions it aims to answer are:

  • - if TPM502 is safe and well tolerated.
  • - if TPM502 can induce modifications in parameters indicating that it may induce tolerance to gluten.
Participants will:
  • - undergo 1-day gluten challenge during screening and after administration of TPM502 or placebo.
- receive 2 infusions of TPM502 or placebo, 2 weeks apart

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Topas Therapeutics GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Knut Lundin, MD
Principal Investigator Affiliation Oslo University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Finland, Netherlands, Norway, Sweden

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

This is a multi center, double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with CeD. The patient´s participation in the study comprises 3 phases: screening period, treatment period and follow-up period. Patients fulfilling the eligibility criteria will be randomized to receive two infusions of TMP502 (or placebo) at the same dose level. Patients will undergo a second GC one week after the second infusion of TPM502. The study includes 4 cohorts of patients, each cohort will receive escalating doses of TPM502 (or placebo).

Arms & Interventions


Experimental: TPM502

Placebo Comparator: placebo


Drug: - TPM502

TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5

Other: - Placebo


Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CRST Oy, Turku, Finland





Turku, , FI-20520

Site Contact

Mika Scheinin, MD


+41 (0)79 5722414

Centre for Human Drug Research, Leiden, Netherlands




Centre for Human Drug Research

Leiden, , 2333 ZA

Site Contact

Naomi Klarenbeek, MD


+41 (0)79 5722414

Oslo, Norway




Oslo University Hospital HF - Rikshospitalet

Oslo, , 0372

Site Contact

Knut Lundin, MD


+41 (0)79 5722414

University Hospital of North-Norway, Tromsø, Norway




University Hospital of North-Norway

Tromsø, , 9038

Site Contact

Rasmus Goll, MD


+41 (0)79 5722414

Uppsala, Sweden




Clinical Trial Consultants, Uppsala University

Uppsala, , 752 37

Site Contact

Per M Hellström, MD


+41 (0)79 5722414

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

PO Box 544, Ambler, PA 19002

Phone: 215-325-1306

Toll-Free: 844-856-6692

Press Room / Media Inquiries

Contact Information

The information found on this website is not intended to be a replacement or substitute for professional medical treatment or for professional medical advice relative to a specific medical condition. We urge you to always seek the advice of your physician. There is no replacement for personal medical treatment and advice from your personal physician.