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Abstract
The primary objective of the DESIGNATE study is to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes mellitus (T1DM) that induces changes in T cell phenotypes observed with alefacept therapy in new-onset T1DM.
Participants will be age 8-45 and within 18 months of T1DM diagnosis.
DESIGNATE is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in new onset T1DM.
Participants will be randomized 1:1:1:1 to one of four possible siplizumab dosing arms. All dosing arms will receive weekly siplizumab doses for a total of 12 weeks. After the completion of treatment, participants will undergo follow-up visits at weeks 12, 24, 36 and 52 which include longitudinal MMTTs. Blood samples for mechanistic analyses will be obtained during the treatment phase and thereafter. Adults aged 18- 45 will be enrolled initially at the study sites.
About This Study
The goal of this study is to see how the experimental study drug, siplizumab, can block or weaken the cells that attack beta cells in the pancreas. This would allow the beta cells to continue to function and produce insulin.
About the Study Drug - Siplizumab
Siplizumab is an experimental anti-CD2 monoclonal antibody medication, which targets the immune pathway that may block or reduce the T cells that attack the beta cells in the pancreas. Siplizumab has been given to patients with psoriasis and several other diseases in experimental studies. Siplizumab has never been used in people with type 1 diabetes mellitus (T1DM). Siplizumab has not been approved by the FDA to treat any illness, including T1DM.
Participating in the DESIGNATE Study
There are four treatment groups in this study. You cannot choose your group. A computer randomly picks who will be in each group. There is no placebo group. Eligible participants will be randomly assigned to receive twelve weekly siplizumab injections at one of the following doses:
- 0.08 mg/kg
- 0.12 mg/kg
- 0.18 mg/kg
- 0.22 mg/kg
You and your study doctor will know which study group you are assigned to.
DESIGNATE is a 52-week Research Study
| Treatment Period | 3 months (12 weeks) | 12 weekly clinic visits (at which the participant receives weekly injections of the study drug) |
| Follow-up Period | 9 months (40 weeks) | 4 clinic visits (at weeks 12, 24, 36 and 52) |
Participation will also involve intensive diabetes management while you are in the study. Participants will do this with the help of their regular doctor or local diabetes care team. If needed, the study team will work with their doctor to help keep their diabetes under good control.
Do you Qualify for this Clinical Trial?
You may be eligible to participate in the DESIGNATE Study if you:
- Are between the ages of 8 and 45
- Have been diagnosed with type 1 diabetes within the last 18 months
- Are in good general health