DUET-CD: A study of an investigational study medication in participants with Moderately to Severely Active Crohn's Disease
General Information:
The purpose of the DUET study is to evaluate the efficacy and safety of the investigational combination therapy of two investigational medications in participants with moderately to severely active Crohn's disease.
Eligibility:
You may be able to take part in the DUET study if you meet the following criteria:
- Age range is 18-65 years, inclusive.
- Have been diagnosed with CD for at least three months.
- Have moderately to severely active CD.
- Have previously demonstrated lack of initial response, responded initially but then lost response with continued therapy, or was intolerant to 1 or more Advanced drug therapies (ADTs) at a dose approved for the treatment of CD.
Study Details:
Study description/explanation of participation:
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The study will last up to 256 weeks. During this time, you will have study visits approximately every 4 weeks.
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The study medicine will be administered by injection given subcutaneously (under the skin)
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You may receive a placebo (containing no active medication) or the investigational medicine. The chance of being assigned to Placebo is 9%
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If you initially receive a placebo in the primary stage of the study and you do not respond you will be switched to the active medication after 24-weeks. You will already have started the maintenance phase at this stage.
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Study participants will receive study-required medical care at no cost
Description of treatment or intervention (mechanism of action):
The investigational combined study medication is being tested to see if it will reduce inflammation in the intestines. It will be administered by injection given subcutaneously (under the skin). The co-formulation of the medicine was first studied in a Phase 2a study for Ulcerative Colitis and is being tested for Crohn’s disease for the first time. It is not yet approved for CD in any country. Therefore, it can only be used in a research study such as this one.
Participation requirements:
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Come to all study visit appointments
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Complete a diary and bring it with you to appointments
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Tell the study doctor/staff about any health problems you have during the study
Possible risks and side effects:
Because we are learning about the study medications in combination, all possible side effects and risks related to the study medicine are not known and there is the potential that you may experience side effects. All potential side effects will be discussed by the study staff before you begin the study.
Side effects may range from mild and unpleasant to serious, or even life-threatening. If you do experience side effects and/or discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be continuously monitored.