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58 Crohn's Disease Trials Near You
Power is an online platform that helps thousands of Crohn's Disease patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerRO7790121 for Crohn's Disease
Columbus, Ohio
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Short Bowel, Pregnancy, Infections, Others
Must Not Be Taking:Anti-TL1A Therapy
600 Participants Needed
Risankizumab for Crohn's Disease
Hilliard, Ohio
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.
Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.
Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Indeterminate Colitis, Others
Must Not Be Taking:P19 Inhibitors
276 Participants Needed
Individualized Infliximab Dosing for Crohn's Disease
Columbus, Ohio
Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment.
The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:6 - 22
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Anti-TNF Use, Others
Must Be Taking:Infliximab
180 Participants Needed
Guselkumab for Crohn's Disease
Columbus, Ohio
This trial is testing guselkumab, a medication that reduces inflammation, in patients with moderate to severe Crohn's disease. It works by blocking a protein called IL-23, which helps to lower inflammation in the body. Guselkumab is a monoclonal antibody that selectively inhibits IL-23 and has shown efficacy in treating inflammatory conditions like psoriasis and Crohn's disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Indeterminate Colitis, Others
350 Participants Needed
Mirikizumab for Crohn's Disease
Columbus, Ohio
This trial is testing mirikizumab to see if it can help people with Crohn's disease feel better over a long time and ensure it is safe. The drug works by reducing gut inflammation.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Cancer, Important Infections, Hypersensitivity, Others
778 Participants Needed
Guselkumab for Crohn's Disease
Columbus, Ohio
This trial is testing guselkumab, a medication that reduces inflammation, in patients with Crohn's disease. It aims to find the best dose and check its safety and effectiveness. The medication works by calming the immune system to reduce symptoms.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Symptomatic Strictures, Others
1409 Participants Needed
Upadacitinib Maintenance Therapy for Crohn's Disease
Columbus, Ohio
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Infections, Hypersensitivity, Dysplasia, Others
747 Participants Needed
Risankizumab for Crohn's Disease
Columbus, Ohio
This trial tests risankizumab, a medication for Crohn's disease, in patients who have already responded well to it. The goal is to see if continued use can maintain their improvement by reducing inflammation in the digestive tract. Risankizumab is approved by the FDA for treating moderate to severe Crohn's disease.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Colonic Dysplasia, Colon Cancer, Lymphoproliferative Disease, Others
Must Be Taking:Risankizumab
1336 Participants Needed
Vedolizumab + Adalimumab/Ustekinumab for Crohn's Disease
Columbus, Ohio
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment.
The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A.
Each participant will be followed up for at least 26 weeks after the last dose of treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Abdominal Abscess, Tuberculosis, Hepatitis B, Others
Must Not Be Taking:Anti-integrin Antibodies
100 Participants Needed
2'-FL Supplement for Inflammatory Bowel Disease
Columbus, Ohio
This trial tests 2'-FL, a sugar from breast milk, as a dietary supplement for young IBD patients in stable remission. It aims to boost good gut bacteria and improve gut health by increasing butyrate levels. 2'-FL, a human milk oligosaccharide, has been shown to promote the growth of beneficial gut bacteria and improve gut health in various studies.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:11 - 25
Key Eligibility Criteria
Disqualifiers:Active IBD, Celiac, Diabetes, Others
Must Be Taking:Anti-TNF Therapy
116 Participants Needed
Targeted Therapies for Crohn's Disease
Columbus, Ohio
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Ostomy, Others
Must Not Be Taking:P19 Inhibitors
500 Participants Needed
VTX958 for Crohn's Disease
Columbus, Ohio
This trial is testing a new medication called VTX958 to help people with moderate to severe Crohn's Disease. The goal is to see if it can reduce inflammation in the intestines and improve symptoms. The study will involve several phases over a period of up to three years.
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
132 Participants Needed
Nivolumab for Cancer
Columbus, Ohio
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Chemotherapy, Radiotherapy, Allogeneic Transplant, Others
Must Not Be Taking:Anticancer Investigational Agents
300 Participants Needed
TAK-279 for Crohn's Disease
Dublin, Ohio
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation.
The participants will be treated with TAK-279 for 52 weeks (1 year).
During the study, participants will visit their study clinic 15 times.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Ostomy, Others
268 Participants Needed
Obefazimod for Crohn's Disease
Hilliard, Ohio
This study has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase.
The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies.
The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared with placebo in subjects who are enrolled in the Extension Phase.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Malignancy, Hepatitis, Others
Must Not Be Taking:Natalizumab, Α4β1 Integrin Agonists
212 Participants Needed
RO7790121 for Crohn's Disease
Beavercreek, Ohio
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Short Bowel, Others
Must Not Be Taking:Anti-TL1A Therapy
425 Participants Needed
CDPATH™ Management Tool for Crohn's Disease
Beavercreek, Ohio
This trial is testing CDPATH™, a tool that predicts the risk of complications from Crohn's disease over time. It targets adults with Crohn's disease to help them and their doctors make informed treatment decisions. CDPATH™ uses health data to create a visual risk profile for each patient.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Bowel Stricture, Abdominal Surgery, Others
Must Not Be Taking:Investigational Agents
200 Participants Needed
TEV-48574 for Inflammatory Bowel Disease
Beavercreek, Ohio
This trial tests a new drug called TEV-48574, given as a shot periodically, in adults with inflammatory bowel disease. It aims to see how well the drug works, how safe it is, and how the body reacts to it.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Major Surgery, Others
218 Participants Needed
Guselkumab for Pediatric Crohn's Disease
Dayton, Ohio
This trial tests guselkumab, an anti-inflammatory medication, on children with Crohn's Disease who initially responded well to it. The goal is to see if the benefits last over several months by reducing immune system activity. Guselkumab has shown effectiveness in treating moderate-to-severe psoriasis and psoriatic arthritis.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Symptomatic Strictures, Abscess, Recent Surgery, Others
120 Participants Needed
Mirikizumab for Pediatric Crohn's Disease
Dayton, Ohio
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.
Study periods for the intervention-specific appendix (ISA) will be as follows:
* A 12-week induction period
* A maintenance period from Week 12 to Week 52, and
* A safety follow-up period up to 16 weeks.
The study will last about 74 weeks and may include up to 19 visits.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Symptomatic Strictures, Stenosis, Short Gut, Others
90 Participants Needed
Why Other Patients Applied
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
Risankizumab vs Ustekinumab for Crohn's Disease
Springboro, Ohio
This trial is testing a new drug, risankizumab, against an existing drug, ustekinumab, to see which works better for adults with moderate to severe Crohn's Disease. The drugs help by reducing gut inflammation. Participants will receive the drugs through injections and be monitored over time. Risankizumab has been studied as a maintenance therapy for moderately to severely active Crohn's disease in previous trials.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Indeterminate Colitis, Others
Must Not Be Taking:Biologics, Investigational Agents
527 Participants Needed
Oral Etrasimod for Crohn's Disease
Cincinnati, Ohio
This trial is testing a new oral medication called etrasimod for adults with severe Crohn's disease who haven't had success with other treatments. The medication aims to reduce gut inflammation by calming the immune system. The study will last several years and includes different stages to determine the best dosage and long-term effects. Etrasimod is also being tested for ulcerative colitis and may avoid issues that can lead to treatment failure with other therapies.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Short-bowel Syndrome, Others
375 Participants Needed
Upadacitinib for Crohn's Disease
Cincinnati, Ohio
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Non-compliance, Others
107 Participants Needed
Combination Therapy for Crohn's Disease
Cincinnati, Ohio
This trial is testing a new medication called JNJ-78934804 to see if it works better than two existing treatments for autoimmune conditions. The study will compare their effectiveness over several months.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Surgery, Abscess, Malignancy, Infections, Others
Must Be Taking:Biologics
703 Participants Needed
Remote Monitoring for Inflammatory Bowel Disease
Cincinnati, Ohio
The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization.
The investigators will address the following specific aims:
1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care.
2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Ileostomy, Colostomy, Imminent Surgery, Others
Must Not Be Taking:Oral Corticosteroids
123 Participants Needed
Cell Therapy for Crohn's Disease
Cincinnati, Ohio
This trial tests AVB-114, a new treatment using healing cells, for patients with hard-to-heal anal wounds from Crohn's disease. The treatment places these cells on a special patch to reduce inflammation and promote healing.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Hepatitis, HIV, Cancer, Pregnancy, Others
Must Not Be Taking:Steroids
60 Participants Needed
Medical Cannabis for Chronic Pain
Sandusky, Ohio
This trial will investigate if medical cannabis can effectively reduce pain and improve quality of life for patients with chronic conditions. The study will gather data through an online questionnaire about patients' use of cannabis and its effects. Medical cannabis interacts with the body's natural system to help manage pain and other symptoms. Medical cannabis has been increasingly studied and used as an alternative treatment for managing chronic pain, with numerous studies supporting its potential benefits.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:7+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Suicidality, Psychosis, Others
200000 Participants Needed
Mirikizumab + Tirzepatide for Crohn's Disease
Westlake, Ohio
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.
The maximum duration of this study is up to 61 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Type 1 Diabetes, Others
290 Participants Needed
Upadacitinib for Crohn's Disease
Cleveland, Ohio
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.
Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.
Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Abscess, Bowel Strictures, Others
110 Participants Needed
Risankizumab for Pediatric Crohn's Disease
Cleveland, Ohio
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \< 18 years old who have had intolerance or inadequate response to other therapies.
Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 110 pediatric participants with CD will be enrolled at around 100 sites worldwide.
Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 17
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Immunodeficiency, Abscess, Others
110 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do Crohn's Disease clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Crohn's Disease clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Crohn's Disease trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Crohn's Disease is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Crohn's Disease medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Crohn's Disease clinical trials?
Most recently, we added Mirikizumab + Tirzepatide for Crohn's Disease, Mirikizumab for Pouchitis and RO7790121 for Crohn's Disease to the Power online platform.
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