A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Simponi
Product Name: Golimumab
Product Code: CNTO148
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration
Sponsors
Janssen Biologics BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is male or female. 2. Is 6 to 21 years of age, inclusive, with minimal weight of 30 kg. 3. 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) -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 inclusion criterion 3. 4. Has a plasma glucose of 7.8 to 11.0 mmol/L (140 to 199 mg/dL) at the 120-minute timepoint of a 2h-OGTT, OR have a plasma glucose of >200 mg/dL (>11.1 mmol/L) at the 30, 60, or 90 minute timepoint of a 2h-OGTT OR have a HbA1c =5.7% but =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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: -HbA1c =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. In the absence of unequivocal hyperglycemia, results should be confirmed by repeat testing.3 2. Has a history of moderate or severe progressive or uncontrolled liver or renal insufficiency, significant cardiac (including congestive heart failure), vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or psychiatric disease (such as serious depression, including suicidality). 3. Has a presence or history of malignancy. 4. Has a presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or clinically significant hepatomegaly or splenomegaly. 5. Has an immune deficiency syndrome (eg, 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. 6. Has other autoimmune diseases (eg, RA, pJIA, PsA, AS, multiple sclerosis, celiac disease, systemic lupus erythematosus) excluding clinically stable autoimmune thyroiditis whether treated or untreated. 7. Has a concomitant diagnosis or history of demyelinating disease, such as but not limited to multiple sclerosis or Guillain-Barre Syndrome. 8. Has known or suspected intolerance or hypersensitivity to human proteins, antibody fragments, or monoclonal antibodies, including golimumab or its excipients, or known allergies or severe sensitivity to latex (refer to the golimumab and VarioJect Investigator's Brochures).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic Stage 2 T1D.;Secondary Objective: The secondary objective is to assess the PK and immunogenicity of golimumab in children, adolescents, and young adults with pre-symptomatic Stage 2 T1D.;Primary end point(s): Safety Endpoints -Proportion of participants with treatment-emergent AEs and serious adverse events (SAE) through Week 26 and Week 52. -Proportion of participants with treatment-emergent infections through Week 26 and Week 52. -Proportion of participants with study treatment injection site reactions throughout the study. -Related AE’s and SAE’s reported at the final safety contact point at Week 78.;Timepoint(s) of evaluation of this end point: Safety endpoint assessed at Week 26, 52 and 78. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic and Immunogenicity -Summary of serum golimumab concentrations and the PK profile after induction and maintenance dosing. -Incidence and titers of antibodies to golimumab.;Timepoint(s) of evaluation of this end point: Endpoint assessed at week 52. | — |
Countries
Finland, Sweden
Contacts
Public ContactClinical Registry Group
Janssen Biologics, BV
Outcome results
None listed