Ustekinumab for Type 1 Diabetes (UST1D2 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: University of British Columbia
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests Ustekinumab, a drug used for psoriasis, in adults aged 18-35 with recent-onset type 1 diabetes. The drug aims to protect and regenerate insulin-producing cells by blocking harmful immune cells. This could reduce the need for insulin injections.
Do I need to stop my current medications for this trial?
Yes, you may need to stop certain medications. The trial excludes participants who have used medications known to influence glucose tolerance within 30 days prior to the first study drug dose. It also excludes those with prior or current treatment affecting T1D or immunological status.
What data supports the idea that Ustekinumab for Type 1 Diabetes is an effective treatment?
The available research does not provide any data on Ustekinumab for Type 1 Diabetes. Instead, the studies focus on other drugs like adalimumab, golimumab, tocilizumab, anakinra, and infliximab for conditions such as juvenile idiopathic arthritis and rheumatoid arthritis. Therefore, there is no information here to support the effectiveness of Ustekinumab for Type 1 Diabetes.
12345What safety data is available for Ustekinumab (Stelara)?
Ustekinumab (Stelara) has been studied for various conditions, including psoriasis, Crohn's disease, and inflammatory bowel diseases. Safety data indicates it is generally safe, but some adverse effects have been reported, such as eosinophilic pneumonia in psoriasis treatment. It is considered a safe and effective option for treating cutaneous manifestations of inflammatory bowel diseases and paradoxical skin reactions. However, more studies are needed to determine optimal dosing for conditions beyond psoriasis. In Crohn's disease, it has a favorable safety profile, though data in elderly patients is limited.
678910Is the drug Ustekinumab a promising treatment for Type 1 Diabetes?
Ustekinumab, known as Stelara, is a drug that has shown promise in treating several conditions like psoriasis and psoriatic arthritis. It works by targeting specific proteins in the immune system, which can help reduce inflammation. While it is not yet proven for Type 1 Diabetes, its success in other immune-related conditions suggests it could be a promising option.
711121314Eligibility Criteria
This trial is for 18-35 year olds recently diagnosed with Type 1 Diabetes, who still produce some insulin and have not used medications affecting glucose tolerance in the last month. Participants must be free from significant diseases, HIV, Hepatitis B/C, tuberculosis, and cannot be pregnant or planning pregnancy soon.Inclusion Criteria
I am between 18 and 35 years old.
I am between 18 and 35 years old.
I have been diagnosed with type 1 diabetes.
I have been diagnosed with type 1 diabetes.
I have tested positive for a diabetes-related autoantibody.
I have tested positive for a diabetes-related autoantibody.
Exclusion Criteria
I have used medication that affects blood sugar levels in the last 30 days.
I do not have, nor have I ever had, an active tuberculosis infection.
I have not had a serious infection in the last 6 weeks.
I am able to understand information and make decisions about my health.
I haven't had major surgery in the last 30 days and don't expect to need any during the study.
Participant Groups
The study tests Ustekinumab's ability to preserve insulin-producing cells in newly diagnosed Type 1 Diabetics against a placebo. The goal is to see if patients can become insulin-free or need less insulin by protecting these cells.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: UstekinumabExperimental Treatment1 Intervention
Week 0: Loading dose of 6mg/kg Ustekinumab Intravenously.
Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg Ustekinumab subcutaneously.
Weeks 28, 52, 78: Non-dosing visits where a Mixed Meal Tolerance Test will be administered.
Total of 11 visits
Group II: Saline Solution - PlaceboPlacebo Group1 Intervention
Patients allocated to receive placebo will receive respective amounts of a saline-placebo at the same intervals.
Week 0: Loading dose of 6mg/kg saline intravenously.
Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg saline subcutaneously.
Weeks 28, 52, 78: Non-dosing visits where a Mixed Meal Tolerance Test will be administered.
Total of 11 visits
Ustekinumab is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Stelara for:
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
🇺🇸 Approved in United States as Stelara for:
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
🇨🇦 Approved in Canada as Stelara for:
- Moderate to severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active Crohn's disease
- Moderately to severely active ulcerative colitis
🇯🇵 Approved in Japan as Stelara for:
- Plaque psoriasis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
BCDiabetesVancouver, Canada
Mount Sinai Hospital/UHNToronto, Canada
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
Janssen, LPIndustry Sponsor
Juvenile Diabetes Research FoundationCollaborator
References
Outcome of Juvenile Idiopathic Arthritis Associated Uveitis in Two Disease Subtypes. [2022]This study aims to evaluate the efficacy of adalimumab as a first line biologic agent in specific subtypes of juvenile idiopathic arthritis (JIA) patients with associated uveitis.
Usefulness of adalimumab in the treatment of refractory uveitis associated with juvenile idiopathic arthritis. [2022]To assess the efficacy and safety of adalimumab in patients with juvenile idiopathic arthritis (JIA) and associated refractory uveitis.
Golimumab in refractory uveitis associated to juvenile idiopathic arthritis: multicentre study of 7 cases and literature review. [2018]To assess the efficacy of golimumab (GLM), a fully humanised anti-TNF-α monoclonal antibody, in refractory juvenile idiopathic arthritis (JIA)-associated uveitis.
Short-term outcomes in patients with systemic juvenile idiopathic arthritis treated with either tocilizumab or anakinra. [2021]To investigate real-world short-term outcomes among patients with systemic JIA starting tocilizumab or anakinra.
Targeted treatment with a combination of traditional DMARDs produces excellent clinical and radiographic long-term outcomes in early rheumatoid arthritis regardless of initial infliximab. The 5-year follow-up results of a randomised clinical trial, the NEO-RACo trial. [2022]To study whether adding initial infliximab to remission-targeted initial combination-DMARD treatment improves the long-term outcomes in patients with early rheumatoid arthritis (RA).
[Ustekinumab-induced eosinophilic pneumonia during the course of ustekinumab therapy for plaque psoriasis]. [2015]Ustekinumab (Stelara(®)) is efficacious in severe cutaneous psoriasis. Numerous adverse effects have been reported but treatment withdrawal is rarely required. The present case concerns eosinophilic pneumonia treated with ustekinumab.
Extrapolating Pharmacodynamic Effects From Adults to Pediatrics: A Case Study of Ustekinumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis. [2021]Ustekinumab (STELARA) is a human monoclonal antibody against interleukins-12 and -23 for the treatment of adult and adolescent (≥ 12 to
Ustekinumab for the treatment of paradoxical skin reactions and cutaneous manifestations of inflammatory bowel diseases. [2021]Ustekinumab (STELARA), a human monoclonal antibody directed against IL-12 and IL-23, is FDA-approved to treat psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Increasing recognition of paradoxical skin reactions induced by older biologic therapies used for inflammatory bowel diseases (IBD), such as, adalimumab and infliximab, has led to the investigation of ustekinumab for the treatment of the cutaneous and gastrointestinal manifestations of IBD. In addition, ustekinumab may show efficacy in treating paradoxical cutaneous reactions to tumor necrosis factor-alpha (TNF-α) inhibitors. A search of the Medline/PubMed database, with additional citations obtained from the references section of relevant articles, yielded 22 articles that were included in this review. Ustekinumab is a safe and effective option for treating the cutaneous manifestations of IBD, such as, metastatic Crohn's disease and pyoderma gangrenosum. It is also an effective treatment for TNF-α inhibitor-induced paradoxical skin reactions, such as, psoriasis that do not remit spontaneously or with conventional treatment. Additional studies should focus on the optimal dosing of ustekinumab for dermatologic conditions beyond psoriasis.
Real-World Effectiveness and Safety of Ustekinumab in Elderly Crohn's Disease Patients. [2023]The efficacy and safety profile of ustekinumab (UST) in Crohn's disease (CD) is favorable; however, data in elderly patients are lacking. We aimed to assess the safety and efficacy of UST in elderly CD.
Baseline peripheral blood mononuclear cell (PBMC) transcriptomics before ustekinumab treatment is linked with Crohn Disease clinical response at 1 year. [2023]Ustekinumab (Stelara), a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23, is used for Crohn Disease (CD), and the documented clinical remission rate after one year was observed in about 50% of patients. We aimed to identify predictors for a clinical response using peripheral blood obtained from CD patients just before ustekinumab treatment initiation.
Ustekinumab: a review of its use in psoriatic arthritis. [2021]Ustekinumab (Stelara(®)) is a human monoclonal antibody that binds to the shared p40 subunit of interleukin (IL)-12 and IL-23, blocking signalling of their cognate receptors. It is established in the treatment of moderate-to-severe plaque psoriasis, but recently received approval in adults with active psoriatic arthritis. Tumour necrosis factor (TNF) inhibitors remain first-line biological agents for the treatment of psoriatic arthritis, but alternative agents are needed. This article summarises the pharmacology of ustekinumab and reviews its use in phase 3 trials in psoriatic arthritis. In these trials, subcutaneous ustekinumab 45 or 90 mg was significantly more effective than placebo, as determined by American College of Rheumatology response criteria at week 24. The drug was also associated with significantly greater efficacy than placebo with regard to secondary endpoints, including the Psoriasis Area and Severity Index ≥ 75 % response, enthesitis and dactylitis scores, radiographic progression and Health Assessment Questionnaire-Disability Index scores. Response to ustekinumab was maintained during long-term therapy (up to week 100), and was achieved with and without concomitant methotrexate. Ustekinumab was generally well tolerated, and the tolerability profile in psoriatic arthritis was similar to that reported in plaque psoriasis. Throughout long-term ustekinumab treatment, serious infection or major cardiovascular adverse events occurred rarely. More data are needed to clearly define the place of ustekinumab in psoriatic arthritis treatment algorithms. Meanwhile the drug is a valuable additional option for patients with psoriatic arthritis in whom the response to previous non-biological disease-modifying antirheumatic drugs has been inadequate, or for those who have failed anti-TNF therapy.
Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab. [2018]Ustekinumab (Stelara®), a human monoclonal antibody targeting the p40-subunit of interleukin (IL)-12 and IL-23, is indicated for moderate to severe plaque psoriasis and psoriatic arthritis. In large multicenter, prospective trials assessing efficacy and safety of ustekinumab increased rates of severe infections have not been observed so far.
Off-label uses of ustekinumab. [2023]Ustekinumab (brand name Stelara®) is a human interleukin-12 and -23 antagonist and has been indicated for the treatments of moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. This review aims to synthesize and interpret the literature evaluating the off-label uses of ustekinumab. We performed searches in PubMed and ClinicalTrials.gov for clinical trials, observational studies, case series, and case reports evaluating label uses of ustekinumab. Studies evaluated the efficacy of ustekinumab for the following conditions: other types of psoriasis (expect plaque psoriasis and psoriatic arthritis), pityriasis rubra pilaris, hidradenitis suppurativa, atopic dermatitis, pyoderma gangrenosum, et al. Based on the available literature, ustekinumab appears to be a potential treatment choice for many other diseases. However, more clinical trials data are needed to adequately assess the safety and efficacy of ustekinumab for the treatment of these conditions.
Long-term safety of ustekinumab for psoriasis. [2015]The biologic, Ustekinumab (Stelara®, Centocor, Inc., Malvern, PA, USA), is a fully human monoclonal antibody with a high affinity for the shared p40 subunit of interleukins 12 and 23 (IL-12 and IL-23). Approved for use in treating moderate-to-severe psoriasis in 2009, there has been considerable interest in the long-term safety of ustekinumab.