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

• ClinicalTrials.gov Identifier: NCT03298542
• Recruitment Status: Completed
• First Posted: October 2, 2017
• Last Update Posted: September 16, 2021
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Pre-Symptomatic Type 1 Diabetes	Drug: Golimumab; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 1b Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes
• Actual Study Start Date: October 16, 2017
• Actual Primary Completion Date: December 21, 2020
• Actual Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
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; Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.; Other Name: SIMPONI
Placebo Comparator: Group 2: Placebo; Participants will receive a SC matching placebo to golimumab.	Drug: Placebo; Matching placebo to golimumab.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Serum Concentration of Golimumab [ Time Frame: Through Week 52 ]
2. Incidence of Antibodies to Golimumab [ Time Frame: Through Week 52 ]

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

• 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

Contacts and Locations

Locations

United States, Colorado

UC Denver-Colorado Barbara Davis Center, University of Colorado SOM Pediatric Endocrinology

Aurora, Colorado, United States, 80045

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

Finland

Oulu University Hosp. - Oulu

Oulu, Finland, FI-90014

Tampere University Hospital

Tampere, Finland, FI-33521

Turku University Hospital

Turku, Finland, 20520

Sweden

Linkoping University Hospital

Linkoping, Sweden, SE 58185

Lund University Hospital/Skåne

Lund/Malmo, Sweden, 205 02

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

More Information

Additional Information:

Link to results on EudraCT registry. 

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03298542
• Other Study ID Numbers: CR108354; 2017-000225-12 ( EudraCT Number ); CNTO148DML1001 ( Other Identifier: Janssen Research & Development, LLC )
• First Posted: October 2, 2017
• Last Update Posted: September 16, 2021
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Golimumab; Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs