Ustekinumab Clinical Trials

What Is Ustekinumab?

Ustekinumab is an FDA-approved medication for Crohn Disease. It is a biologic agent that works by targeting and binding to specific proteins in the body, Interleukin-12 (IL-12) and Interleukin-23 (IL-23). These proteins are known to play a key role in inflammatory processes. By inhibiting IL-12 and IL-23, ustekinumab helps to reduce inflammation.

In addition to its approved use for Crohn Disease, ustekinumab is also being investigated for the treatment of other inflammatory conditions such as psoriasis, psoriatic arthritis, and ulcerative colitis. Clinical trials for ustekinumab began in 2005, with the latest trial projected to conclude in 2026. Across 176 trials, a total of 51,267 participants have been enrolled to study this drug.

Uses and Conditions Under Study

Ustekinumab is primarily studied for its role in treating chronic inflammatory conditions, with a significant focus on gastrointestinal and skin disorders.

• Inflammatory Bowel Diseases (IBD): Ustekinumab is extensively studied for conditions like Crohn Disease (38 trials), Crohn's Disease (12 trials), Ulcerative Colitis (11 trials), Colitis, Ulcerative (5 trials), Inflammatory Bowel Diseases (5 trials), and Inflammatory Bowel Disease (4 trials). These are chronic disorders characterized by inflammation of the gastrointestinal tract, often causing symptoms like abdominal pain and diarrhea. Ustekinumab's mechanism of inhibiting IL-12 and IL-23 helps to reduce this gut inflammation.
• Psoriasis and Psoriatic Arthritis: The drug is also a focus in dermatology, with trials for Psoriasis (36 trials), Plaque Psoriasis (9 trials), and Psoriatic Arthritis (7 trials). Psoriasis is a skin condition marked by chronic inflammation, while psoriatic arthritis involves joint inflammation. Ustekinumab aims to improve skin resolution and reduce inflammation in these conditions by targeting the same inflammatory pathways.
• Other Conditions: Ustekinumab is also being explored in trials for conditions such as common variable immunodeficiency (CVID) with associated gastrointestinal inflammation, and sarcoidosis. Additionally, 5 trials have included healthy participants, typically to assess the drug's safety profile and how it is processed by the body.

Dosing

Ustekinumab is administered as an injection, either intravenously (IV) for induction or subcutaneously (SC) for maintenance. The specific dosing regimen can vary depending on the condition and phase of treatment.

For induction, common intravenous doses studied include 130 mg or approximately 6 mg/kg, often given as a single dose or multiple doses over a few weeks. Following induction, maintenance therapy typically involves subcutaneous injections. Strengths studied for subcutaneous administration include 45 mg and 90 mg, with frequencies such as every 8 weeks (q8w) or every 12 weeks (q12w). Some studies also investigate a subcutaneous dose of 100 mg every 8 weeks.

Investigational dosing regimens include subcutaneous administration every 4 weeks (q4w). While most studies focus on adult populations, ustekinumab has also been studied in pediatric patients with inflammatory bowel disease and juvenile psoriatic arthritis, though specific pediatric dosing guidelines are often determined by the clinician's experience and disease activity. Biosimilar versions of ustekinumab, such as SB17 and FYB202, are also being evaluated for their safety and efficacy.

Side Effects

The most commonly reported side effect for Ustekinumab was nasopharyngitis (common cold).

In clinical trials involving over 17,000 patients, side effects reported by patients taking Ustekinumab, compared to those taking a placebo, included:

• Nasopharyngitis: 11.3% of patients on Ustekinumab experienced this, compared to 9.7% on placebo.
• Upper respiratory tract infection: 10.7% of patients on Ustekinumab experienced this, compared to 11.2% on placebo.
• Headache: 6.6% of patients on Ustekinumab experienced this, compared to 5.7% on placebo.
• Arthralgia (joint pain): 6.4% of patients on Ustekinumab experienced this, compared to 5.9% on placebo.
• Abdominal pain: 4.4% of patients on Ustekinumab experienced this, compared to 3.8% on placebo.
• Sinusitis: 3.8% of patients on Ustekinumab experienced this, compared to 3.4% on placebo.
• Nausea: 3.7% of patients on Ustekinumab experienced this, which was the same rate as 3.7% on placebo.
• Diarrhea: 3.5% of patients

  Currently Recruiting Trials

  Researchers are actively recruiting participants for clinical trials involving Ustekinumab, exploring its potential across various conditions and treatment strategies. These studies aim to understand how Ustekinumab works, how it compares to other treatments, and how its use can be optimized for patients.

  • A Phase 3 study, NCT07116967, sponsored by Bristol-Myers Squibb, is evaluating the long-term safety of Deucravacitinib versus Ustekinumab in participants with Plaque Psoriasis, targeting an enrollment of 3040 individuals.
  • For patients with Crohn's disease (CD) and ulcerative colitis (UC), a Phase 4 trial, NCT07303686, from McGill University Health Centre, is investigating if disease remission can be maintained by de-escalating Ustekinumab therapy. This study plans to enroll 115 participants.
  • The M.D. Anderson Cancer Center is sponsoring a Phase 2 study, NCT06807593, to determine if Ustekinumab can help control immune checkpoint inhibitor-related diarrhea and/or colitis in cancer patients, with an enrollment goal of 10.
  • A Phase 2 trial, NCT06453317, led by the Medical University of Lodz, is comparing Ustekinumab, Infliximab, and a combination of both therapies for moderately to severely active Ulcerative Colitis, seeking 172 participants.
  • The University Medical Center Groningen is conducting a Phase 1 study, NCT05725876, using quantitative fluorescence molecular imaging to understand Ustekinumab's drug distribution in inflamed tissue in Crohn's Disease and Psoriasis, with an enrollment target of 56.
  • For children and adolescents aged 6 to less than 18 years with moderate to severe Plaque Psoriasis, UCB Biopharma SRL is sponsoring a Phase 3 study, NCT06425549, to compare the efficacy and safety of Bimekizumab to Ustekinumab, aiming for 168 participants.
  • Takeda is sponsoring a Phase 4 study, NCT06045754, exploring the effects of Vedolizumab combined with either Adalimumab or Ustekinumab in adults with moderate to severe Crohn's Disease, with an enrollment goal of 100.
  • An observational study, NCT06997055, by Celltrion HealthCare France, is tracking patients who switch to Steqeyma®, an Ustekinumab biosimilar, for Crohn's Disease or Plaque Psoriasis, planning to include 225 individuals.
  • The Sixth Affiliated Hospital, Sun Yat-sen University, is conducting a Phase 4 trial, NCT06520397, to evaluate the efficacy and safety of dual-target therapy (Ustekinumab combined with Upadacitinib) versus intensified Ustekinumab monotherapy in Crohn's disease patients, with a target enrollment of 214.

  Where to Participate

  Ustekinumab clinical trials are broadly accessible across the United States, with study sites located in 38 states, encompassing 140 cities and a total of 191 sites. This wide reach ensures many patients have the opportunity to participate.

  Top recruiting locations include:

  • Dallas, Texas (4 sites)
  • Los Angeles, California (4 sites)
  • Phoenix, Arizona (4 sites)
  • Miami, Florida (4 sites)
  • Tampa, Florida (3 sites)
  • Portland, Oregon (3 sites)
  • Oklahoma City, Oklahoma (3 sites)
  • San Antonio, Texas (3 sites)
  • Chapel Hill, North Carolina (3 sites)
  • Scottsdale, Arizona (3 sites)

  Eligibility for these trials generally includes individuals aged 6 to 89 years, of all genders. Many studies also welcome healthy volunteers and children, depending on the specific research focus.

  Development Timeline

  The journey of Ustekinumab in clinical research began on December 14, 2005, with the latest trials projected to conclude by May 2026. Since its inception, Ustekinumab has been investigated in a robust pipeline of 176 clinical trials, collectively enrolling over 51,267 participants.

  Initial development focused on conditions like IBS-C and hyperphosphatemia, but the research quickly expanded. Janssen Research & Development, LLC has been a primary driver, sponsoring 35 trials, alongside other key contributors like Centocor, Inc. and the National Institute of Allergy and Infectious Diseases (NIAID).

  The development has progressed through various phases:

  • 58 trials reached Phase 3, evaluating efficacy and safety in large patient groups.
  • 31 trials were conducted in Phase 2, exploring initial effectiveness and dosage.
  • 21 trials are in Phase 4, focusing on post-market surveillance and long-term effects.
  • 13 trials were in Phase 1, assessing initial safety.

  Over time, the scope of Ustekinumab's investigation broadened significantly. It moved into major inflammatory conditions such as Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, and Psoriatic Arthritis. Further research has explored its potential in a diverse range of conditions, including various inflammatory bowel diseases, different forms of psoriasis, and even certain types of cancer-related complications, demonstrating a continuous commitment to understanding its full therapeutic potential.