Pre-Symptomatic Type 1 DiabetesPhase 1NCT03298542
A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
A Phase 1 study testing Golimumab in people with Pre-Symptomatic Type 1 Diabetes, run by Janssen Research & Development, LLC at 8 sites in 3 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus (T1D). Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Pre-Symptomatic Type 1 Diabetes
- What is being tested?
- Golimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 16 Oct 2017to 1 Jun 2021
- 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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Is positive for at least 2 of the following diabetes-related autoantibodies obtained at study screening: Glutamic acid decarboxylase-65 (GAD-65) Autoantibodies, Insulinoma-associated 2 Autoantibodies (IA-2A), Zinc Transporter-8 (ZnT8), Islet Cell Cytoplasmic Autoantibodies (ICA), or Insulin Autoantibodies (IAA). Participants with a confirmed documented history of at least 2 positive diabetes-related autoantibodies but who screen positive on only 1 autoantibody are considered to have met this criteria
- Has a plasma glucose of 7.8 to 11.0 millimoles per liter (mmol/L) (140 to 199 milligrams per deciliter (mg/dL)) at the 120-minute timepoint of a 2-hour(h)-oral glucose tolerance test (OGTT), OR have a plasma glucose of greater than (>) 200 mg/dL (> 11.1 mmol/L) at the 30, 60, or 90 minute timepoint of a 2h-OGTT OR have a hemoglobin A1c (HbA1c) greater than or equal to (>=) 5.7 percent (%) but less than (<) 6.5% ([>=] 39 to <48 millimoles per moles [mmol/mol]) evaluated at screening
- Is medically stable on the basis of physical examination, medical history, laboratory results, and vital signs performed at screening
- If a woman of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Week 0 visit
- Must be up-to-date or have initiated catch up vaccines with routine age-appropriate immunizations and have received vaccines, or at least initiated vaccine series and have a completion plan, that are recommended for immune suppressed individuals according to current local recommendations before the first dose of study treatment
Who cannot join
- Has a current or prior diagnosis of diabetes mellitus (Type 1, Type 2, or gestational) or meet the metabolic criteria diagnostic of diabetes mellitus obtained at screening including: hemoglobin A1c (HbA1c) greater than or equal to 6.5 (%) (48 mmol/mol), or fasting plasma glucose (>=) 7.0 mmol/L (126 mg/dL) (fasting: no intake >= 8 hours), or plasma glucose >= 11.1 mmol/L (200 mg/dL) 2 hours post OGTT, or random plasma glucose >= 11.1 mmol/L (200 mg/dL) in those with symptoms consistent with hyperglycemia crisis
- Has a presence or history of malignancy
- Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
- Has other autoimmune diseases (for example, rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), multiple sclerosis, celiac disease, systemic lupus erythematosus) excluding clinically stable autoimmune thyroiditis whether treated or untreated
- Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non healing skin wound or ulcer
- Has a clinically active infection with Epstein-Barr virus (EBV) or an EBV polymerase chain reaction (PCR) viral load serology of >= 10,000 copies per milliliter (mL) at study screening
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- Has a clinically active infection with cytomegalovirus (CMV) or a CMV PCR viral load serology of >= 10,000 copies per mL at study screening
- Is infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) or at screening tests positive for HIV, HBV, or HCV
- Has any of the following tuberculosis (TB) screening criteria: a history of latent or active TB prior to screening; signs or symptoms suggestive of active TB upon medical history and/or physical examination; recent close contact (within 3 months) with a person with known or suspected active TB; a positive QuantiFERON-TB test result at screening, the participant should be excluded from the study; a chest radiograph taken within 3 months prior to the first administration of study treatment read by a qualified radiologist consistent with current, active TB or old, inactive TB
- Has a current or prior use of any type and form of exogenous insulin or oral/intravenous (IV) antihyperglycemic treatment
- Has known or suspected intolerance or hypersensitivity to human proteins, antibody fragments, or monoclonal antibodies, including golimumab or its excipients
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States3 sites
UC Denver-Colorado Barbara Davis Center, University of Colorado SOM Pediatric Endocrinology
Aurora, Colorado, 80045
University of Virginia
Charlottesville, Virginia, 22903
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Finland3 sites
Oulu University Hosp. Oulu
Oulu, FI-90014
Tampere University Hospital
Tampere, FI-33521
Turku University Hospital
Turku, 20520
Sweden2 sites
Linkoping University Hospital
Linköping, SE 58185
Lund University Hospital/Skåne
Lund/Malmo, 205 02
About this study
Official title: A Phase 1b Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
The purpose of this study is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus (T1D).
- Conditions
- Pre-Symptomatic Type 1 Diabetes
- Being tested
- Golimumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Also called SIMPONI
Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
PlaceboDrug
Matching placebo to golimumab.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Golimumab | Experimental | Participants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area. Receives: Drug: Golimumab |
| Group 2: Placebo | Placebo comparator | Participants will receive a SC matching placebo to golimumab. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Week 26
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Week 52
Percentage of Participants With Treatment-Emergent Infections
Measured: Up to Week 26
Percentage of Participants With Treatment-Emergent Infections
Measured: Up to Week 52
Percentage of Participants With Study Treatment Injection Site Reactions
Measured: Up to Week 26
Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78
Measured: Week 52 to Week 78
Secondary outcomes (2)
Serum Concentration of Golimumab
Measured: Through Week 52
Incidence of Antibodies to Golimumab
Measured: Through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start16 Oct 2017
- Primary completion21 Dec 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Symptomatic Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298542
- Sponsor's protocol ID
- CR108354
- Other IDs
- 2017-000225-12, CNTO148DML1001, 2017
- Status last verified
- Jan 2025
- First submitted
- 15 Sep 2017
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03298542
- Acronym / sponsor ID
- CR108354
- Conditions
- Pre-Symptomatic Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 2 Oct 2017 (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 purpose of this study is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic stage 2 type 1 diabetes mellitus (T1D).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Golimumab | Experimental | Drug: GolimumabParticipants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area. |
| Group 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a SC matching placebo to golimumab. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Is positive for at least 2 of the following diabetes-related autoantibodies obtained at study screening: Glutamic acid decarboxylase-65 (GAD-65) Autoantibodies, Insulinoma-associated 2 Autoantibodies (IA-2A), Zinc Transporter-8 (ZnT8), Islet Cell Cytoplasmic Autoantibodies (ICA), or Insulin Autoantibodies (IAA). Participants with a confirmed documented history of at least 2 positive diabetes-related autoantibodies but who screen positive on only 1 autoantibody are considered to have met this criteria
- Has a plasma glucose of 7.8 to 11.0 millimoles per liter (mmol/L) (140 to 199 milligrams per deciliter (mg/dL)) at the 120-minute timepoint of a 2-hour(h)-oral glucose tolerance test (OGTT), OR have a plasma glucose of greater than (>) 200 mg/dL (> 11.1 mmol/L) at the 30, 60, or 90 minute timepoint of a 2h-OGTT OR have a hemoglobin A1c (HbA1c) greater than or equal to (>=) 5.7 percent (%) but less than (<) 6.5% ([>=] 39 to <48 millimoles per moles [mmol/mol]) evaluated at screening
- Is medically stable on the basis of physical examination, medical history, laboratory results, and vital signs performed at screening
- If a woman of childbearing potential must have a negative highly sensitive serum test (beta-human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Week 0 visit
- Must be up-to-date or have initiated catch up vaccines with routine age-appropriate immunizations and have received vaccines, or at least initiated vaccine series and have a completion plan, that are recommended for immune suppressed individuals according to current local recommendations before the first dose of study treatment
Key exclusion criteria (11 listed)
- Has a current or prior diagnosis of diabetes mellitus (Type 1, Type 2, or gestational) or meet the metabolic criteria diagnostic of diabetes mellitus obtained at screening including: hemoglobin A1c (HbA1c) greater than or equal to 6.5 (%) (48 mmol/mol), or fasting plasma glucose (>=) 7.0 mmol/L (126 mg/dL) (fasting: no intake >= 8 hours), or plasma glucose >= 11.1 mmol/L (200 mg/dL) 2 hours post OGTT, or random plasma glucose >= 11.1 mmol/L (200 mg/dL) in those with symptoms consistent with hyperglycemia crisis
- Has a presence or history of malignancy
- Has an immune deficiency syndrome (for example, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous disease), or bone marrow or organ transplantation, or a disease associated with lymphopenia
- Has other autoimmune diseases (for example, rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), multiple sclerosis, celiac disease, systemic lupus erythematosus) excluding clinically stable autoimmune thyroiditis whether treated or untreated
- Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non healing skin wound or ulcer
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 |
|---|---|---|
| GolimumabAlso: SIMPONIParticipants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area. | Drug | Group 1: Golimumab |
| PlaceboMatching placebo to golimumab. | Drug | Group 2: Placebo |
Primary outcome
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 26
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 52
Percentage of Participants With Treatment-Emergent Infections
Time frame: Up to Week 26
Percentage of Participants With Treatment-Emergent Infections
Time frame: Up to Week 52
Percentage of Participants With Study Treatment Injection Site Reactions
Time frame: Up to Week 26
Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78
Time frame: Week 52 to Week 78
2 secondary outcomes
Serum Concentration of Golimumab
Time frame: Through Week 52
Incidence of Antibodies to Golimumab
Time frame: Through Week 52
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 3 Feb 2025.
- Link to results on EudraCT registry.Link provided by the sponsor.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Golimumab in people with Pre-Symptomatic Type 1 Diabetes, run by Janssen Research & Development, LLC at 8 sites in 3 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 5 inclusion and 11 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Finland, 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 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 of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Week 26). The study lists 6 primary outcomes in all. 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 3 Feb 2025.