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CompletedNCT03298542Updated Feb 3, 2025

A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes

A Phase 1 interventional study of Golimumab and Placebo in Pre-Symptomatic Type 1 Diabetes, sponsored by Janssen Research & Development, LLC. Completed at 8 sites in 3 countries. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
6 Years to 21 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Pre-Symptomatic Type 1 Diabetes
03

Who can participate

Ages eligible
6 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Group 1: Golimumab

    Participants will receive subcutaneous (SC) golimumab for 26 weeks, where doses will be based on weight and/or body surface area.

    Drug: Golimumab

  • Placebo comparator
    Group 2: Placebo

    Participants will receive a SC matching placebo to golimumab.

    Drug: Placebo

Interventions

  • DrugGolimumab

    Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.

    Also known as: SIMPONI

  • DrugPlacebo

    Matching placebo to golimumab.

05

What researchers measure

Primary outcomes

  1. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Week 26

  2. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Week 52

  3. Percentage of Participants With Treatment-Emergent Infections

    Time frame: Up to Week 26

  4. Percentage of Participants With Treatment-Emergent Infections

    Time frame: Up to Week 52

  5. Percentage of Participants With Study Treatment Injection Site Reactions

    Time frame: Up to Week 26

  6. Number of Participants With Treatment Related AEs and SAEs Reported From Week 52 to Week 78

    Time frame: Week 52 to Week 78

Secondary outcomes

  1. Serum Concentration of Golimumab

    Time frame: Through Week 52

  2. Incidence of Antibodies to Golimumab

    Time frame: Through Week 52

06

Study locations

8 sites
  • UC Denver-Colorado Barbara Davis Center, University of Colorado SOM Pediatric Endocrinology
    Aurora, Colorado 80045, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
  • Oulu University Hosp. Oulu
    Oulu, FI-90014, Finland
  • Tampere University Hospital
    Tampere, FI-33521, Finland
  • Turku University Hospital
    Turku, 20520, Finland
  • Linkoping University Hospital
    Linkoping, SE 58185, Sweden
  • Lund University Hospital/Skåne
    Lund/Malmo, 205 02, Sweden
07

References and documents

08

Registry details

Key details

Study ID
NCT03298542
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Oct 2, 2017
Start date
Oct 16, 2017
Primary completion
Dec 21, 2020
Completion
Jun 1, 2021
Last update
Feb 3, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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