Guselkumab for Ulcerative Colitis

(ASTRO Trial)

Not currently recruiting at 404 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Janssen Research & Development, LLC

Must not be taking: Prohibited medications

Disqualifiers: Crohn's disease, Surgery, COVID-19, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of guselkumab for individuals with ulcerative colitis (UC), a condition that causes inflammation and sores in the colon. The study aims to achieve clinical remission, which means reducing symptoms and inflammation. Participants will receive injections of either guselkumab or a placebo, which contains no active treatment. Those who have had UC for at least 12 weeks and have not found success with other treatments may be suitable candidates for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Do I need to stop my current medications to join the trial?

The trial information mentions that participants cannot be receiving prohibited medications and treatments, but it does not specify which ones. It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that guselkumab is likely to be safe for humans?

Research has shown that guselkumab is generally safe for use. In one study, 26% of patients taking guselkumab experienced clinical remission after 12 weeks, compared to only 7% of those taking a placebo. This indicates that the treatment was effective and did not cause significant harm.

Another study found that 22.6% of patients achieved clinical remission with guselkumab, while only 7.9% did with a placebo over the same 12-week period. These findings suggest that serious side effects are uncommon.

Guselkumab is also approved for treating other conditions, indicating a good safety record. While all treatments carry some risks, the evidence so far supports that guselkumab is safe for many people. It is important to consult healthcare providers to understand personal risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Researchers are excited about guselkumab for treating ulcerative colitis because it targets a specific protein called IL-23, which plays a key role in inflammation. Unlike other standard treatments like aminosalicylates, corticosteroids, or TNF inhibitors that broadly suppress the immune system, guselkumab offers a more targeted approach, potentially reducing side effects and improving efficacy. This targeted action could mean more precise control of inflammation for patients, offering hope for better outcomes with fewer risks.

What evidence suggests that guselkumab might be an effective treatment for ulcerative colitis?

Research has shown that guselkumab may help treat ulcerative colitis (UC). In one study, 56.1% of patients taking guselkumab experienced clinical remission, compared to only 21.4% of those taking a placebo. Another study found that over 70% of patients stayed in remission for an extended period. This trial will test guselkumab in different dosing regimens, with some participants receiving guselkumab and others receiving a placebo. Guselkumab blocks a protein called IL-23, which reduces inflammation in the gut, a major issue in UC. Overall, these findings suggest that guselkumab could effectively treat people with moderately to severely active UC. ^{3 6 7 8 9}

Who Is on the Research Team?

Janssen Research & Development, LLC Clinical trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with moderately to severely active ulcerative colitis who haven't responded well to or can't tolerate standard treatments. They must have been diagnosed at least 12 weeks before the study starts and cannot be on certain medications, have recent or upcoming surgery that could affect results, just rectal UC, other types of colitis, Crohn's disease, or an active COVID-19 infection.

Inclusion Criteria

Signed informed consent form

My ulcerative colitis is moderate to severe according to the Mayo score.

I was diagnosed with ulcerative colitis more than 12 weeks ago.

Exclusion Criteria

I currently have a severe case of COVID-19.

My ulcerative colitis affects only my rectum.

I haven't had surgery in the last 8 weeks and don't plan to during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive guselkumab or placebo subcutaneous injections to evaluate efficacy and clinical remission

12 weeks

Extended Treatment

Continued treatment to assess long-term efficacy and safety, including endoscopic and symptomatic improvements

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events

Up to 268 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Guselkumab

Trial Overview

The trial is testing three different doses of a medication called Guselkumab against a placebo in people with ulcerative colitis. The main goal is to see if Guselkumab helps patients achieve clinical remission better than no treatment (placebo).

How Is the Trial Designed?

Group I: Group 2: Guselkumab Experimental Treatment 2 Interventions

Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.

Group II: Group 1: Guselkumab Experimental Treatment 2 Interventions

Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.

Group III: Group 3: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo SC injection.

Guselkumab is already approved in United States, European Union for the following indications:

Approved in United States as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Approved in European Union as Tremfya for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Moderately to severely active ulcerative colitis

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Tofacitinib is the first Janus kinase inhibitor approved for treating moderate-to-severely active ulcerative colitis, specifically for patients who have not responded to conventional therapies.

Despite advancements in treatment options, 25-40% of ulcerative colitis patients still do not respond to therapies, highlighting the need for effective alternatives like tofacitinib.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is tofacitinib a game-changing drug for ulcerative colitis? Magro, F., Estevinho, MM.[2021]

In a study of 334 ulcerative colitis patients treated with tofacitinib, approximately 35% achieved clinical remission at 12, 24, and 52 weeks, indicating its effectiveness in real-world settings.

While tofacitinib had a low incidence of serious adverse events, nearly 45% of patients lost their response after reducing the dose, highlighting the need for careful management and monitoring, especially for those with higher risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REMIT-UC: Real-World Effectiveness and Safety of Tofacitinib for Moderate-to-Severely Active Ulcerative Colitis: A Canadian IBD Research Consortium Multicenter National Cohort Study. Ma, C., Panaccione, R., Xiao, Y., et al.[2023]

Guselkumab is an approved treatment for moderate-to-severe plaque psoriasis, specifically designed to inhibit interleukin 23 (IL-23), which plays a key role in the inflammatory process of the disease.

By blocking IL-23 from binding to its receptor, guselkumab disrupts the IL-17 pathway, which is crucial for the activation of type 17 helper T cells, thereby reducing inflammation and symptoms in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab: First Global Approval. Markham, A.[2019]

In the QUASAR Phase 2b Induction Study, guselkumab, an interleukin-23p19 antagonist, demonstrated significant efficacy in treating moderately to severely active ulcerative colitis, with 61.4% and 60.7% of patients achieving clinical response at week 12 for the 200 mg and 400 mg doses, respectively, compared to only 27.6% for placebo.

The safety profile of guselkumab was comparable to that of the placebo, indicating that it is a safe treatment option for patients who have not responded adequately to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 2b Induction Study. Peyrin-Biroulet, L., Allegretti, JR., Rubin, DT., et al.[2023]

In a study involving 268 patients with moderate-to-severe ulcerative colitis in Japan, vedolizumab demonstrated a favorable safety profile, with a low incidence of adverse drug reactions (4.10%), including mild cases like dizziness and nausea.

Vedolizumab was effective in 84.5% of patients after three doses, showing similar therapeutic responses in both TNFα inhibitor-naïve (85.8%) and experienced patients (82.7%), indicating its potential as a reliable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. Matsuoka, K., Hisamatsu, T., Mikami, Y., et al.[2023]

Tofacitinib, an oral medication that inhibits Janus kinases, has shown effectiveness in inducing and maintaining remission in adults with moderate to severe ulcerative colitis, providing a new treatment option for patients who do not respond to conventional therapies or biologics.

The review focuses on the efficacy and safety of tofacitinib based on randomized controlled trials, highlighting its potential role in the treatment strategy for ulcerative colitis, pending regulatory approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positioning Tofacitinib in the Treatment Algorithm of Moderate to Severe Ulcerative Colitis. Danese, S., D'Amico, F., Bonovas, S., et al.[2019]

In a study involving 214 adults with moderately-to-severely active ulcerative colitis, combination therapy with guselkumab and golimumab resulted in a higher clinical response rate at week 12 (83%) compared to golimumab monotherapy (61%) and guselkumab monotherapy (75%).

The safety profile was generally acceptable, with no deaths or serious complications reported during the treatment period, although some adverse events like infections and anemia were noted, indicating the need for monitoring in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guselkumab plus golimumab combination therapy versus guselkumab or golimumab monotherapy in patients with ulcerative colitis (VEGA): a randomised, double-blind, controlled, phase 2, proof-of-concept trial. Feagan, BG., Sands, BE., Sandborn, WJ., et al.[2023]

Citations

1.

tremfyahcp.com

tremfyahcp.com/ulcerative-colitis/efficacy/

Efficacy in Moderately to Severely Active UC

Discover TREMFYA® (guselkumab) efficacy data in adults with moderately to severely active UC. See full Prescribing & Safety Information.

2.

jnj.com

jnj.com/media-center/press-releases/tremfya-guselkumab-is-first-and-only-il-23-inhibitor-to-demonstrate-sustained-clinical-and-endoscopic-outcomes-with-a-fully-subcutaneous-regimen-through-48-weeks-in-ulcerative-colitis

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to ...

Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39800899/

Guselkumab: A New Therapeutic Option for the Treatment ...

The QUASAR findings suggest guselkumab can provide durable clinical remission and histologic normalization, addressing a significant gap in UC ...

4.

jnj.com

jnj.com/media-center/press-releases/tremfya-guselkumab-delivers-sustained-clinical-and-endoscopic-remission-in-ulcerative-colitis-through-two-years

TREMFYA® (guselkumab) delivers sustained clinical and ...

Data from the QUASAR long-term extension study demonstrate more than 70% of patients were in clinical remission and more than 40% of ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0016508525005220

Efficacy and Safety of Guselkumab Subcutaneous ...

At week 12, significantly greater proportions of participants receiving guselkumab 400 mg achieved clinical remission vs placebo (56.1% vs 21.4%; Δ = 34.9; P < ...

6.

tremfya.com

tremfya.com/ulcerative-colitis/results/

UC: Results & Safety

26% of patients taking TREMFYA ® vs 7% of patients on placebo achieved clinical remission at 12 weeks taking 400 mg SC initial injections. Results with IV

7.

investor.jnj.com

investor.jnj.com/investor-news/news-details/2025/TREMFYA-guselkumab-is-first-and-only-IL-23-inhibitor-to-demonstrate-sustained-clinical-and-endoscopic-outcomes-with-a-fully-subcutaneous-regimen-through-48-weeks-in-ulcerative-colitis/default.aspx

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to ...

Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic ...

8.

prnewswire.com

prnewswire.com/news-releases/tremfya-guselkumab-is-first-and-only-il-23-inhibitor-to-demonstrate-sustained-clinical-and-endoscopic-outcomes-with-a-fully-subcutaneous-regimen-through-48-weeks-in-ulcerative-colitis-302576330.html

TREMFYA® (guselkumab) is first and only IL-23 inhibitor to ...

Patients treated with subcutaneous TREMFYA® achieved clinically meaningful results in both clinical remission (36.7%) and endoscopic ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10910368/

Results From the Phase 3 QUASAR Induction Study

The trial met its primary endpoint, demonstrating clinical remission rates of 22.6% with guselkumab and 7.9% with placebo at week 12 (P<.001; Figure 6). In a ...