Targeted Therapies for Crohn's Disease

(Target CD Trial)

Recruiting at 280 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must not be taking: P19 inhibitors

Disqualifiers: Ulcerative colitis, Ostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for Crohn's disease, which causes inflammation in the digestive tract and leads to symptoms like stomach pain and diarrhea. The study will assess the effectiveness and safety of three targeted therapies—risankizumab (Skyrizi), ABBV-382 (Budigalimab), and lutikizumab—for adults with moderate to severe Crohn's. Participants will be randomly assigned to groups receiving different combinations and forms of these medications. Those who have had Crohn's for at least three months and have not responded well to other treatments might be suitable candidates. Participants must visit a clinic regularly for check-ups, blood tests, and symptom reporting. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are currently on investigational targeted therapies, you may need to stop them at least 30 days before starting the trial, unless your drug levels are undetectable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, risankizumab, also known as SKYRIZI, was generally well-tolerated by people with Crohn's disease. Common side effects included colds, headaches, and joint pain. No new safety issues emerged with long-term use.

For ABBV-382, limited safety information is available. Early studies in healthy adults showed it was manageable, but more data is needed for people with Crohn's disease.

Lutikizumab has been tested for other conditions, and most people tolerated it well. Serious side effects were rare, affecting about 5% of patients in one study.

This trial is in Phase 2, indicating that the treatments have shown some safety in earlier trials, but researchers are still assessing their safety in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Crohn's Disease because they introduce multiple innovative approaches that differ from current options like corticosteroids and TNF inhibitors. Risankizumab and Lutikizumab target specific inflammatory pathways more precisely, potentially offering a more targeted reduction in inflammation. ABBV-382 introduces a different mechanism of action, potentially providing an alternative for patients who don't respond well to existing treatments. Additionally, these therapies offer varied administration methods, such as intravenous (IV) infusions and subcutaneous (SC) injections, which could enhance patient convenience and adherence.

What evidence suggests that this trial's treatments could be effective for Crohn's disease?

Research shows that risankizumab, one of the treatments in this trial, helps treat Crohn's disease (CD). Studies found that about 59% of patients experienced fewer symptoms after three months. ABBV-382, another treatment option in this trial, is a new drug under investigation for CD, with ongoing research to assess its effectiveness. Lutikizumab, also part of this trial, did not show strong results for similar conditions like ulcerative colitis when used alone, but it might be more effective in combination with other drugs. Researchers are exploring whether combining risankizumab with lutikizumab or ABBV-382, as tested in this trial, can provide additional benefits. These treatments aim to help people with moderate to severe CD find relief when other treatments might not work as well. ^{1 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with moderate to severe Crohn's Disease who weigh at least 40 kg and have been diagnosed for over 3 months. They must show intolerance or inadequate response to existing targeted therapies, have a certain level of disease activity, and evidence of inflammation in the bowels.

Inclusion Criteria

My weight is at least 40 kg.

My Crohn's disease activity index (CDAI) score is 220 or more.

My bowel inflammation is confirmed by a specific endoscopy score.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive targeted therapies during the 12-week induction period

12 weeks

Regular visits at a hospital or clinic

Maintenance

Participants continue receiving targeted therapies during the 12-week maintenance period

12 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Extension

Participants may opt into continuation of treatment long-term

Up to 72 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-382
• Lutikizumab
• Risankizumab

Trial Overview The trial is testing three drugs: Risankizumab, ABBV-382, and Lutikizumab. Participants will be randomly assigned to one of these treatments and monitored over a period that includes induction (12 weeks), maintenance (12 weeks), and possibly an extension phase.

How Is the Trial Designed?

Group I: Monotherapy: Risankizumab Experimental Treatment 1 Intervention

Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose B as SC injection.

Group II: Monotherapy: Lutikizumab Experimental Treatment 1 Intervention

Participants will receive Lutikizumab Dose A, Dose B and Dose C as SC injection.

Group III: Monotherapy: ABBV-382 Experimental Treatment 1 Intervention

Participants will receive ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection.

Group IV: Long-Term Extension: Risankizumab Monotherapy Experimental Treatment 1 Intervention

Participants will receive Risankizumab Dose A as IV infusion and/or Risankizumab Dose B as SC injection for up to 72 weeks.

Group V: Combination Therapy: Risankizumab and Lutikizumab Experimental Treatment 2 Interventions

Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and Lutikizumab Dose A, Dose B and Dose C as SC injection.

Group VI: Combination Therapy: Risankizumab and ABBV-382 Experimental Treatment 2 Interventions

Participants will receive Risankizumab Dose A as IV infusion and Risankizumab Dose C as SC injection; and ABBV-382 Dose A as IV infusion and ABBV-382 Dose B as SC injection.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Infliximab and adalimumab are effective in inducing clinical response and maintaining remission in Crohn's disease, while infliximab is also effective for ulcerative colitis, highlighting their role as key therapies for these conditions.

Vedolizumab, an anti-α4β7 integrin antibody, shows a favorable efficacy and safety profile, making it a promising option for treating Crohn's disease, while other monoclonal antibodies like ustekinumab are also being developed to target specific inflammatory pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current directions of biologic therapies in inflammatory bowel disease. Reenaers, C., Louis, E., Belaiche, J.[2023]

In a phase 2b study involving 246 patients with moderately to severely active Crohn's disease, briakinumab did not meet the primary endpoint of clinical remission at week 6, but showed numerically greater rates of remission and response at weeks 6, 12, and 24 compared to placebo.

Briakinumab demonstrated a safety and tolerability profile similar to that of placebo, with comparable rates of serious adverse events and other safety concerns, suggesting it may be a viable treatment option for Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Briakinumab for treatment of Crohn's disease: results of a randomized trial. Panaccione, R., Sandborn, WJ., Gordon, GL., et al.[2019]

Vedolizumab, a gut-selective integrin blocker for Crohn's disease and ulcerative colitis, showed a similar rate of serious adverse events (35.9%) compared to anti-TNF drugs (32.1%) in a study analyzing 499 reports for vedolizumab and 119,620 for anti-TNFs.

The study identified 22 groups of adverse events associated with vedolizumab, including 9 with serious outcomes, suggesting potential cardiovascular risks; however, these findings are preliminary and require further investigation through long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. Cross, RK., Chiorean, M., Vekeman, F., et al.[2023]

In the STARDUST phase 3b trial, ustekinumab demonstrated significant long-term efficacy in treating Crohn's disease, with clinical remission rates reaching 68.4% among patients in the long-term extension after 104 weeks.

The study showed a favorable safety profile with no new safety signals, and the flexible dosing strategy allowed for both escalation and de-escalation of treatment based on patient response, maintaining effective clinical and endoscopic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trial: Clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease: Results from the long-term extension period of STARDUST. Peyrin-Biroulet, L., Vermeire, S., D'Haens, G., et al.[2023]

Subcutaneous risankizumab, a selective anti-IL-23 antibody, has been shown to be an effective maintenance therapy for patients with moderately to severely active Crohn's disease, achieving higher rates of clinical remission and endoscopic response compared to placebo in a study involving 542 participants.

The treatment was well tolerated, with adverse event rates similar across all groups, indicating that risankizumab could be a safe new option for patients who need ongoing management of their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Ferrante, M., Panaccione, R., Baert, F., et al.[2022]

In a study of 1087 patients with Crohn's disease and ulcerative colitis, vedolizumab demonstrated a favorable safety profile, with a low overall infection rate of 6.3% and non-infectious adverse events primarily being arthralgias (2.9%).

Factors such as active smoking and the use of multiple immunosuppressive agents were found to significantly increase the risk of infections in patients receiving vedolizumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases. Meserve, J., Aniwan, S., Koliani-Pace, JL., et al.[2021]

Natalizumab is effective for inducing clinical remission in patients with moderately to severely active Crohn's disease, showing significant improvement compared to placebo in multiple studies involving 1771 participants.

Despite its efficacy, natalizumab is associated with serious risks, including progressive multifocal leukoencephalopathy (PML), which limits its use to select patients and raises concerns about safety, especially since no reliable tests exist to predict PML risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natalizumab for induction of remission in Crohn's disease. Nelson, SM., Nguyen, TM., McDonald, JW., et al.[2022]

In a systematic review of eight studies involving 1281 Crohn's disease patients who had previously been treated with anti-TNF agents, a second biological therapy was found to be significantly more effective than placebo in inducing remission and response, with odds ratios of 2.2 and 1.9, respectively.

No single biological agent was shown to be superior to others in efficacy, although adalimumab showed relatively better results for inducing remission, highlighting the need for further research to optimize treatment strategies for patients who do not respond to initial therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review with Network Meta-Analysis: Efficacy of Induction Therapy with a Second Biological Agent in Anti-TNF-Experienced Crohn's Disease Patients. Pagnini, C., Siakavellas, SI., Bamias, G.[2022]

In a long-term safety study involving 2,243 patients with ulcerative colitis (UC) and Crohn's disease (CD), vedolizumab demonstrated a favorable safety profile, with no new safety concerns or unexpected adverse events over an average treatment duration of 42.4 months for UC and 31.5 months for CD.

Vedolizumab maintained clinical response in a significant portion of patients, with 33% of UC patients and 28% of CD patients achieving clinical remission after 400 weeks of treatment, indicating its efficacy for long-term management of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of vedolizumab for inflammatory bowel disease. Loftus, EV., Feagan, BG., Panaccione, R., et al.[2021]

Vedolizumab demonstrated the ability to maintain steroid-free clinical remission in 27.2% of patients with Crohn's disease and 40.5% of patients with ulcerative colitis at week 54, indicating its efficacy in long-term treatment.

The safety profile of vedolizumab was reasonable, with no deaths reported and only 7.2% of patients experiencing severe adverse events, although a notable number of patients, especially those with Crohn's disease, experienced a loss of response during the first year of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multicentre cohort study. Amiot, A., Serrero, M., Peyrin-Biroulet, L., et al.[2022]

In a long-term study of 65 patients with moderate-to-severe Crohn's disease, risankizumab was well tolerated over a median of 33 months, with no new safety concerns and a low rate of serious adverse events (24.6 events/100 patient-years).

Efficacy was maintained throughout the study, with over 71% of patients achieving clinical remission and more than 42% achieving endoscopic remission, indicating that risankizumab remains effective for long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Risankizumab Treatment in Patients with Crohn's Disease: Results from the Phase 2 Open-Label Extension Study. Ferrante, M., Feagan, BG., Panés, J., et al.[2022]

In a 52-week study involving 24 patients with Crohn's disease who previously lost response to infliximab, adalimumab demonstrated significant efficacy, with clinical remission rates increasing from 35% at baseline to 58% at week 52.

Adalimumab was well tolerated, with no patients experiencing intolerance and no serious toxicities reported, indicating it is a safe option for maintaining remission in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. Peyrin-Biroulet, L., Laclotte, C., Bigard, MA.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06548542

NCT06548542 | Study of Targeted Therapies for the ... This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-885

Study of Targeted Therapies for the Treatment of Adult ... Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling) ... Risankizumab and ABBV-382 are given as an injection ...

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/33415199/abbvies-innovative-approach-to-crohns-disease-a-study-update/

AbbVie's Innovative Approach to Crohn's Disease: A Study ... The study aims to evaluate the effectiveness and adverse events of targeted therapies for adult participants with moderate to severe Crohn's ...

4. mountsinai.org mountsinai.org/clinical-trials/study-of-targeted-therapies-for-treatment-of-adult-participants-with-moderate-to-severe-crohns-disease

Study of Targeted Therapies for the Treatment of Adult ... The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study ...

5. clinicaltrials.eu clinicaltrials.eu/inn/humanised-igg1-kappa-monoclonal-antibody-against-alfa4beta7-integrin/

ABBV-382: A Promising Treatment for HIV and Crohn's ... ABBV-382 is a new medication currently being studied for its potential to treat various conditions, including HIV (Human Immunodeficiency Virus) and Crohn's ...

6. synapse.patsnap.com synapse.patsnap.com/drug/019e9c96d65e4dcf825dd343f79c3b64

ABBV-382 - Drug Targets, Indications, Patents A randomized, single-blind, placebo-controlled, phase 1 study to evaluate the safety and pharmacokinetics of single doses of ABBV-382 in healthy adult Chinese ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8783908/

First-in-human phase 1 study of budigalimab, an anti-PD-1 ... In conclusion, these data demonstrate that budigalimab has a manageable safety profile with evidence of biologic and clinical activity in patients with ...

8. nature.com nature.com/articles/s41591-025-03993-0

Budigalimab, an anti-PD-1 inhibitor, for people living with ... Herein, we report on budigalimab as a potential treatment for HIV-1 infection. Study M19-939 (NCT04223804) was a phase 1b randomized, placebo- ...