Diabetes Mellitus, Type 1Phase 2STRIDENCT06025110
A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
A Phase 2 study testing TCD601 in people with Diabetes Mellitus, Type 1, run by ITB-Med LLC at 26 sites in 5 countries.
Trial summary
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- TCD601
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 23 Jan 2023to 24 Jul 2025
- Phase
- Phase 2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to understand the study requirements and provide written informed consent before any study assessment is performed
- Male or female patients ≥ 18 to 45 years of age
- A diagnosis of type 1 diabetes
Who cannot join
- Women who are pregnant, lactating, or planning on pregnancy during the study
- History of cancer
- History of heart disease
- Recent infection
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
United Kingdom13 sites
University of Birmingham
Birmingham
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6DA
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY
Ninewells Hospital
Dundee, DD1 9SY
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, L7 8YE
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Guy's and St. Thomas' NHS Foundation Trust
London
East Kent Hospitals University NHS Foundation Trust
Margate, CT9 4AN
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
Northern Care Alliance NHS Foundation Trust
Salford, M6 8HD
Swansea Bay University Health Board
Swansea
Spain6 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Universitari de Girona Dr. Josep Trueta
Girona, 17007
Hospital General de Segovia
Segovia, 40002
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
Italy4 sites
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, 88100
San Raffaele Hospital
Milan, 20132
Luigi Sacco Hospital
Milan, 20157
University of Siena
Siena, 53100
About this study
Official title: A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- TCD601, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCD601Biological
Investigational Product
PlaceboOther
Comparator
| Study group | Role | What they receive |
|---|---|---|
| TCD601 | Experimental | Administered one of three doses of TCD601 over a 12 week treatment period. Receives: Biological: TCD601 |
| Placebo | Placebo comparator | Placebo is administered over a 12 week treatment period. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in beta-cell function as compared to placebo at week 52.
Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).
Measured: 52 weeks
Secondary outcomes (1)
Assess the incidence and severity of adverse
Number of adverse events compared to placebo at week 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start23 Jan 2023
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Why it stopped: The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITB-Med LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredrik Juhlin, Study director, ITB-MED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025110
- Sponsor's protocol ID
- TCD601F201
- Acronym
- STRIDE
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
- ClinicalTrials.gov ID
- NCT06025110
- Acronym / sponsor ID
- STRIDE / TCD601F201
- Conditions
- Diabetes Mellitus, Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ITB-Med LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 6 Sep 2023 (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 determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCD601 | Experimental | Biological: TCD601Administered one of three doses of TCD601 over a 12 week treatment period. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo is administered over a 12 week treatment period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to understand the study requirements and provide written informed consent before any study assessment is performed
- Male or female patients ≥ 18 to 45 years of age
- A diagnosis of type 1 diabetes
Key exclusion criteria (4 listed)
- Women who are pregnant, lactating, or planning on pregnancy during the study
- History of cancer
- History of heart disease
- Recent infection
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 |
|---|---|---|
| TCD601Investigational Product | Biological | TCD601 |
| PlaceboComparator | Other | Placebo |
Primary outcome
Change from baseline in beta-cell function as compared to placebo at week 52.
Time frame: 52 weeks
Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).
1 secondary outcome
Assess the incidence and severity of adverse
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- 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.
Fredrik Juhlin study director
ITB-MED
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCD601 in people with Diabetes Mellitus, Type 1, run by ITB-Med LLC at 26 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United Kingdom, Spain, Italy, Belgium, Sweden. 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?
The study was stopped early (reason given: The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.). Results are not available in the source record.
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?
Change from baseline in beta-cell function as compared to placebo at week 52. (time frame: 52 weeks). 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 14 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.