Eosinophilic EsophagitisPhase 1NCT04593251
Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
A Phase 1 study testing CALY-002 in people with Eosinophilic Esophagitis and Celiac Disease, run by Calypso Biotech BV at 13 sites in 5 countries.
Trial summary
This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis, Celiac Disease
- What is being tested?
- CALY-002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 28 Sep 2020to 2 Apr 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A. Healthy Subjects:
- Male or female aged between 18 and 50 years (both inclusive)
- Must be healthy on the basis of the physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead electrocardiogram [ECG] results) performed at screening, in the opinion of the investigator
- Part B. Subjects with Celiac Disease (CeD):
- Male or female ≥ 18 years of age.
- Diagnosis of CeD by intestinal biopsy at least 12 months prior to screening as confirmed by medical records.
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- No histological signs of active CeD at screening
- Gluten-free diet (GFD) for at least 12 consecutive months prior to screening
- Willing to undertake a gluten challenge (intake of approximately 3 g of gluten daily) for 56 consecutive days
- Must be healthy on the basis of physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead ECG results) performed at screening, in the opinion of the investigator.
- Part C. Subjects with Eosinophilic Esophagitis (EoE):
- Male or female ≥ 18 years of age.
- Must have endoscopically confirmed and documented diagnosis of EoE
- Should exhibit active symptoms of dysphagia with more than 3 episodes of dysphagia during a period of 2 weeks during screening.
- Must have clinically active disease
- Must have had a relapsed EoE or did not respond after first line therapy
- Subject must be healthy on the basis of physical examination findings, clinical laboratory tests, medical history, vital signs, and cardiac monitoring (normal 12 lead ECG results) performed at screening, in the opinion of the investigator.
Who cannot join
- Part A. Healthy Subjects excluded:
- Any significant medical condition, laboratory abnormality, or psychiatric illness
- Any condition that confounds the ability to interpret data from the study.
- Currently receiving or has been previously treated with a biologic agent.
- History of anaphylactic reactions to protein therapeutics.
- Has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require parenteral antibiotic administration.
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- Has evidence of SARS-CoV-2 infection and/or subject Is deemed at risk for the coronavirus disease (COVID-19)
- Has had major surgery (including joint surgery) within 8 weeks prior to screening and hospitalisation for a clinically relevant event within the 4 weeks prior to screening.
- Part B. Subjects with Celiac Disease (CeD) excluded:
- A concurrent active autoimmune disease (other than CeD) that requires systematic treatment with immunosuppressants.
- Has severe complication of CeD such as refractory CeD.
- Has active (microscopic) colitis with clinical signs of diarrhoea and abdominal pain.
- Is currently receiving or has been previously treated with a biologic agent.
- Has a history of anaphylactic reactions to protein therapeutics.
- Subject has evidence of SARS-CoV-2 infection and/or subject is deemed at risk for the coronavirus disease (COVID-19).
- Part C: Subjects with Eosinophilic Esophagitis (EoE) excluded:
- Has a hyper-eosinophilic syndrome.
- Has a concurrent active autoimmune disease (other than EoE) that requires treatment with immunosuppressants.
- Has active (microscopic) colitis with clinical signs of diarrhoea and abdominal pain.
- Currently receiving or has been previously treated with a biologic agent.
- Has a history of anaphylactic reactions to protein therapeutics.
- Subject has evidence of SARS-CoV-2 infection and/or subject is deemed at risk for the coronavirus disease (COVID-19).
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Germany5 sites
Charite
Berlin
Universitatsklinikum Erlangen - Hospital
Erlangen
Universitätsklinikum Freiburg - Hospital
Freiburg im Breisgau
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital
Mainz-GE
Klinikum rechts der Isa der Technischen Universitaet Muenchen - Hospital
Munich
Netherlands3 sites
AMC
Amsterdam
Ziekenhuis Rijnstate - Hospital
Arnhem
Maastricht University Medical Center - Hospital
Maastricht
Belgium2 sites
Cliniques Universitaires Saint-Luc - Hospital
Brussels
UZ Leuven
Leuven
About this study
Official title: A Multicentre, SAD, and MAD Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IV Treatment of CALY-002 in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.
Read the detailed description
This is a multi-site, randomized, placebo controlled single and multiple dose escalation study of an anti-IL-15 mAb (CALY-002). The study initiates as placebo controlled, randomized trial with a single ascending dosing part in healthy subjects and commences with a multiple ascending dosing part in participants with Celiac Disease undergoing a gluten challenge and includes open label multiple dose expansion cohorts in participants with Eosinophilic Esophagitis.
- Conditions
- Eosinophilic Esophagitis, Celiac Disease
- Being tested
- CALY-002, Placebo
- Keywords
- anti IL-15, CalypsoBiotech, Calypso Biotech, Celiac Disease, Eosinophilic Esophagitis
- Medical subject headings
- Eosinophilic Esophagitis, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALY-002Biological
1-hour intravenous infusion
PlaceboBiological
1-hour intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CALY-002 | Experimental | Not described Receives: Biological: CALY-002 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse event
Measured: through study completion, an average of 3 months post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start28 Sep 2020
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calypso Biotech BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593251
- Sponsor's protocol ID
- CALY-CL19-001
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, SAD, and MAD Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IV Treatment of CALY-002 in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT04593251
- Acronym / sponsor ID
- CALY-CL19-001
- Conditions
- Eosinophilic Esophagitis, Celiac Disease
- Keywords
- anti IL-15, CalypsoBiotech, Calypso Biotech, Celiac Disease, Eosinophilic Esophagitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Calypso Biotech BVIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 19 Oct 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.
This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.
Detailed description
This is a multi-site, randomized, placebo controlled single and multiple dose escalation study of an anti-IL-15 mAb (CALY-002). The study initiates as placebo controlled, randomized trial with a single ascending dosing part in healthy subjects and commences with a multiple ascending dosing part in participants with Celiac Disease undergoing a gluten challenge and includes open label multiple dose expansion cohorts in participants with Eosinophilic Esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALY-002 | Experimental | Biological: CALY-002 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Part A. Healthy Subjects:
- Part B. Subjects with Celiac Disease (CeD):
- Part C. Subjects with Eosinophilic Esophagitis (EoE):
Key exclusion criteria (22 listed)
- Part A. Healthy Subjects excluded:
- Part B. Subjects with Celiac Disease (CeD) excluded:
- Part C: Subjects with Eosinophilic Esophagitis (EoE) excluded:
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 |
|---|---|---|
| CALY-0021-hour intravenous infusion | Biological | CALY-002 |
| Placebo1-hour intravenous infusion | Biological | Placebo |
Primary outcome
Incidence of treatment-emergent adverse event
Time frame: through study completion, an average of 3 months post last dose
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 9 Apr 2024.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CALY-002 in people with Eosinophilic Esophagitis and Celiac Disease, run by Calypso Biotech BV at 13 sites in 5 countries.
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 17 inclusion and 22 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Netherlands, Belgium, Norway, 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 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?
Incidence of treatment-emergent adverse event (time frame: through study completion, an average of 3 months post last dose). 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 NCT04593251, which also lists 1 linked publication.
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 9 Apr 2024.