Today, we will be looking into the latest research and clinical trials focused on Crohn’s disease in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for Crohn’s disease, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of Crohn’s Disease Clinical Trials!
Quick View Table of Crohn’s Disease Clinical Trials
Phase 3 Clinical Trials:
A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn’s Disease
- Sponsor: Janssen Research & Development, LLC
- The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn’s disease.
- Interventions: DRUG: Guselkumab Dose 1 | DRUG: Guselkumab Dose 2 | DRUG: Guselkumab Dose 3 | DRUG: Placebo
- Primary Outcomes Measures: Clinical Remission at Week 12, Clinical Remission is based on Crohn’s Disease Activity Index (CDAI)., Week 12|Endoscopic Response at Week 12, Endoscopic response is based on change from baseline in the Simple Endoscopic Score for Crohn’s Disease (SES-CD)., Week 12
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn’s Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn’s Disease (CD)
- Sponsor: AbbVie
- “Crohn’s disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn’s Disease Activity Index (CDAI).
- Risankizumab is an investigational drug being developed for the treatment of Crohn’s Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide.
- In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks.
- 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.”
- Interventions:DRUG: Risankizumab | DRUG: Risankizumab | DRUG: Ustekinumab | DRUG: Ustekinumab
- Primary Outcomes Measures: Percentage of Participants Achieving Clinical Remission at Week 24, Clinical remission is defined as Crohn’s disease activity index (CDAI)\<150., Week 24 | Percentage of Participants Achieving Endoscopic Remission, Endoscopic remission is defined as Simple Endoscopic Score for Crohn’s Disease (SES-CD) \<= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer., Week 48 |Number of Participants Reporting Adverse Events, An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug., Up to 220 Weeks
A Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease
- Sponsor: Eli Lilly and Company
- The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn’s disease.
- Interventions: DRUG: Mirikizumab | DRUG: Mirikizumab | DRUG: Ustekinumab | DRUG: Ustekinumab | DRUG: Placebo | DRUG: Placebo
- Primary Outcomes Measures: “Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52, Clinical response by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP) Endoscopic response based on Simple Endoscopic Score for Crohn’s Disease (SES-CD) total score, Baseline to Week 52|Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52, Clinical response by PRO based on SF and AP Clinical remission based on CDAI, Baseline to Week 52”
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn’s Disease
- Sponsor: Janssen-Cilag Ltd.
- The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy..
- Interventions: DRUG: Ustekinumab approximately 6 mg/kg (IV) | DRUG: Placebo (SC) | DRUG: Placebo (IV) | DRUG: Ustekinumab 90 mg (SC) Group 1 | DRUG: Ustekinumab 90 mg (SC) Group 2
- Primary Outcomes Measures: Percentage of Participants With Clinical Response at Week 16, Clinical response was defined as greater than or equal to (\>=) 100-point reduction from baseline in Crohn’s disease activity index (CDAI) score or a CDAI score \< 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn’s disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score., Week 16
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
- Sponsor: Celgene
- This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn’s Disease.
- Interventions: DRUG: Ozanimod | OTHER: Placebo
- Primary Outcomes Measures: Proportion of participants with a Crohn’s Disease Activity Index (CDAI) score < 150, Week 12
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn’s Disease Who Completed the Studies M14-431 or M14-433
- Sponsor: AbbVie
- 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.
- Interventions: DRUG: Upadacitinib | DRUG: Placebo for Upadacitinib
- Primary Outcomes Measures: Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn’s Disease Activity Index (CDAI), Clinical remission per CDAI is defined as CDAI \<150., Week 52|Sub-Study 1: Percentage of Participants with Endoscopic Response, Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD) from Baseline., Week 52 | Number of Participants with Adverse Events, An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section., Through Week 240
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA)
- Sponsor: Shire
- The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn’s disease (CD).
- Interventions: DRUG: 25 mg Ontamalimab | DRUG: 75 mg Ontamalimab
- Primary Outcomes Measures: Number of Participants With Treatment Emergent Adverse Events (TEAEs), An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product., From first dose of study drug up to end of study [EOS] (up to 5.79 years)|Number of Participants With Serious Infections, Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator’s assessment., From first dose of study drug up to EOS (up to 5.79 years)|Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time, Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported., From first dose of study drug up to EOS (up to 5.79 years)|Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time, ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported., From first dose of study drug up to EOS (up to 5.79 years)|Number of Participants With Discernible Changes in Vital Signs Over Time, Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported., From first dose of study drug up to EOS (up to 5.79 years)
A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn’s Disease
- Sponsor: AbbVie
- “The study consists of 4 sub-studies, as follows:
- * Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn’s disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
- * Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
- * Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn’s disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
- * Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.
- * OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.”
- Interventions: DRUG: Placebo for Risankizumab SC | DRUG: Risankizumab IV | DRUG: Placebo for Risankizumab IV | DRUG: Risankizumab SC | DRUG: Risankizumab On-Body Injector (OBI)
- Primary Outcomes Measures: “Sub-Study 1: Percentage of Participants With Crohn’s Disease Activity Index (CDAI) Clinical Remission, The CDAI is used to evaluate disease activity in patients with Crohn’s disease. The CDAI clinical remission is defined as a CDAI score of \< 150., Week 52|Sub-Study 1: Percentage of Participants With Endoscopic Response, Endoscopic response defined as decrease from Baseline of the induction study in Simple Endoscopic Score for Crohn’s Disease (SES-CD)., Week 52|Sub-Study 3: Number of Participants With Adverse Events, An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section., Up to Week 220|Sub-Study 4: Percentage of Participants With an Observer Rating of Successful Participant Self Administration, Participant who successfully completed the sequence of critical steps in the instructions for use (IFU) without errors to administer study drug via the OBI at Week 0 and 16., Up to Week 16|Sub-Study 4: Percentage of Participants who had no Potential Hazards, Measured by an observer on the possible use-related hazards checklist for self-administration with OBI at Week 0 and Week 16., Up to Week 16|Sub-Study 4: Percentage of Participants Rating of Acceptability Using Self-Injection Assessment Questionnaire (SIAQ) at Weeks 0, 8, 16, SIAQ evaluations consist of the PRE module, which is self-completed immediately before the first OBI self-injection at baseline, and the POST module, which is self-completed 20 to 40 min following injections at Weeks 0, 8, 16. These modules are completed by participants while alone in a quiet environment. Participants rate each item of the SIAQ. The ratings are later transformed to scores ranging from 0 (worst experience) to 10 (best experience). The domain score is the mean of the item scores included in the domain. Domain scores are calculated only if at least half of the domain items are completed. Item and domain scores from the PRE module are compared with the corresponding item and domain scores from the POST modules., Up to Week 16|Sub-Study 4: Percentage of Participants in CDAI Clinical Remission at Week 0, 16, Clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score., Up to Week 16”
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn’s Disease
- Sponsor: Galapagos NV
- “The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn’s disease (CD) in participants who are biologic-naive and biologic-experienced.
- Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).”
- Interventions: DRUG: Filgotinib | OTHER: Placebo
- Primary Outcomes Measures: “Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn’s Disease Activity Index (CDAI) at Week 10, The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
- Clinical remission was defined as a CDAI of \< 150 points., Week 10|Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10, The Simple Endoscopic Score for Crohn’s Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 – 12 for each segment, and 0 – 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score., Week 10|Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58, The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.
- Clinical remission was defined as a CDAI of \< 150 points., Week 58|Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58, The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 – 12 for each segment, and 0 – 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score., Week 58″
A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn’s Disease
- Sponsor: Takeda
- “The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis and Crohn’s disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant’s condition remains under control or improves during and after treatment with Vedolizumab SC.
- Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study.
- For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens.
- Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study.
- After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.”
- Interventions: DRUG: Vedolizumab SC
- Primary Outcomes Measures: Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant’s Exposure to Long-term Vedolizumab Treatment, Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years., From start of study medication through 18 weeks after the last dose
- Sponsor: Celgene
- This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn’s Disease.
- Interventions: DRUG: Ozanimod | OTHER: Placebo
- Primary Outcomes Measures: Proportion of participants with a Crohn’s Disease Activity Index (CDAI) score < 150, Week 12
Potential Guideline That May Be Affected Includes:
- Management of Crohn’s Disease in Adults
- American College of Gastroenterology
- Publication: March 01, 2018
- Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease
- American Gastroenterological Association
- Publication: May 27, 2021
- Dietary Guidance for Patients with Inflammatory Bowel Disease
- International Organization for the Study of Inflammatory Bowel Diseases
- Publication: February 14, 2020
There you have it – a list of phase 3 Clinical Trials for Crohn’s Disease as of December 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.
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