A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled (Humira), Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Investigational drug in Participants With Moderately to...
Published: 04/04/2019
General Information:
Full Study Title: A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-Controlled (Humira), Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Investigational drug in Participants With Moderately to Severely Active Crohn's Disease [INTREPID]
The primary objectives of this study is to evaluate the efficacy and safety of the investigational drug versus placebo (Stage 1) and versus Humira® (Stage 2) to achieve endoscopic response and clinical remission in participants with moderately to severely active Crohn's Disease (CD) who have failed or are intolerant to conventional therapy (corticosteroids or immunomodulators), or who are biological-treatment naive, have demonstrated a successful response to prior biological treatment, or who have failed or were intolerant to biological treatment.
Eligibility:
Inclusion and Exclusion Criteria are the same for both Stage 1 and Stage 2; however, participants enrolled in Stage 1 will not be permitted to enroll in Stage 2.
Inclusion Criteria:
- Aged 16 to 80 years, inclusive, or minimum age of adult consent according to local regulations, at screening. For participants less than 18 years of age, the participant must weigh at least 40 kg (88 pounds) at screening.
- Diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to screening.
- Moderately to severely active Crohn's Disease.
Exclusion Criteria:
- Participant is unable or unwilling to have endoscopic procedures performed during the study.
- History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
- Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to screening.
- Participant has known history of drug (including opiates) or alcohol abuse.
- Currently enrolled in another investigational device or drug study.
- Participant is pregnant, breastfeeding, or plans to become pregnant during the study.
- Clinically significant infections including history of HIV or chronic hepatitis B or C.
- Received blood products (e.g. blood transfusion) within the preceding month.
Study Details:
Study Description
Stage 1: Patients will be randomly assigned to 1 of 4 treatment groups
- Investigational drug - dose level A
- Investigational drug - dose level B
- Active comparator (Humira®)
- Placebo
You, your doctor and the Sponsor will not know which treatment group you are assigned to for this study. This type of study is called a "double-blind" study.
The study time frame is up to 70 weeks, consisting of-
- A 4-week screening period
- A 52-week treatment period
- An 18-week safety follow up period from the last investigational/placebo matching investigational drug dose
Participants will have an 83% chance of getting an active drug.
Stage 2: Patients will be randomly assigned to 1 of 3 treatment groups
- Investigational drug - dose level A
- Investigational drug - dose level B
- Active comparator (Humira®)
You, your doctor and the Sponsor will not know which treatment group you are assigned to for this study. This type of study is called a "double-blind" study.
The study time frame is up to 70 weeks, consisting of-
- A 4-week screening period
- A 52-week treatment period
- An 18-week safety follow-up period from the last investigational/placebo matching investigational drug dose
Description of Treatment or Intervention (Mechanism of Action)
- Drug: Investigational drug low dose
- Drug: Investigational drug high dose
- Drug: Humira®
- Drug: Placebo
The investigational drug is a human immunoglobulin that selectively binds to human IL-23 with high affinity and prevents IL-23 from interacting with the IL-23 receptor. The roles of IL-23 are believed to be important for the recruitment and activation of a range of inflammatory cells involved in IBD.
Patient Participation Requirements
Participants must meet all eligibility criteria in order to partake in the study. There will be a total of 31 study visits over a period of approximately 70 weeks.
This study will include-
- A screening period
- A treatment period
- A safety follow-up period
After the screening period, the investigational drug will be given through a needle placed in the vein (intravenously) as well as by a subcutaneous (sc) injection (injection through the skin) into the abdomen.
Throughout the study (every 2 weeks)-
- All participants will be administered the same number and type (IV and/or SC) of investigational drug regardless of the treatment group assignment
- The assigned treatment group will not change during the course of the study
- Participants will also be asked to complete an electronic diary at specific timepoints to record their general health information and CD symptoms from screening until they exit the study
- At scheduled clinic visits, participants will also fill out forms about their symptoms and disease
- A colonoscopy will be performed at screening, one time during the study, and at the end of the study
- Blood and stool samples will also be taken at screening and at specific times during the study
- Additional testing and study requirements include: written informed consent, pregnancy testing (females of childbearing potential), highly effective birth control, TB testing, and clinical laboratory tests
***For complete study information please consult with a participating site.
Possible Risks & Side Effects
The study doctor will review all the possible risks and side effects of the investigational drug and active control at screening.