APL-1401 for Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Jiangsu Yahong Meditech Co., Ltd aka Asieris
Must be taking: Oral 5-ASA, Corticosteroids
Must not be taking: Intravenous corticosteroids, JAK inhibitors
Disqualifiers: Crohn's, HIV, Hepatitis, others
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new drug, APL-1401, taken daily by mouth, on patients with severe Ulcerative Colitis. It aims to find the safest and most effective dose over a few weeks.
Will I have to stop taking my current medications?
The trial allows participants to continue taking certain medications like oral 5-ASA and oral corticosteroids if the doses are stable. However, you must stop taking other medications like intravenous corticosteroids, topical 5-ASA, and certain immunosuppressants before joining the trial. Please check with the trial team for specific guidance on your medications.
Eligibility Criteria
Adults aged 18-65 with moderately to severely active Ulcerative Colitis (UC) can join this trial. They must have a UC diagnosis for at least 3 months, a Total Mayo Score of 6-12, and be on stable doses of certain medications. Women must test negative for pregnancy and use two birth control methods; men also need to follow specific contraception guidelines.Inclusion Criteria
I am between 18 and 65 years old.
Exclusion Criteria
I haven't used topical 5-ASA or steroids like enemas or suppositories in the last 2 weeks.
I have not taken JAK inhibitors like tofacitinib or upadacitinib in the last 4 weeks.
I have not taken intravenous corticosteroids in the week before joining.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
1 visit (in-person)
Treatment
Participants receive APL-1401 or placebo orally once daily for 28 days
4 weeks
4 visits (in-person)
Safety Follow-up
Participants are monitored for safety and adverse events after treatment
4 weeks
2 visits (in-person)
Participant Groups
APL-1401 is being tested against a placebo in this study. Participants will randomly receive either the drug or placebo without knowing which one they're getting. The trial includes initial screening, treatment over four weeks, and follows up safety checks until day 58.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: APL-1401Experimental Treatment1 Intervention
On Day 1, patients will be randomized to receive either APL-1401 or placebo in a 5:1 ratio. Patients will receive APL-1401 orally once daily (QD) during the 28-day treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Identically matching placebo capsules once daily for 28 days
APL-1401 is already approved in United States, China for the following indications:
🇺🇸 Approved in United States as APL-1401 for:
- None approved; currently in Phase 1b clinical trial for moderately to severely active ulcerative colitis
🇨🇳 Approved in China as APL-1401 for:
- None approved; currently in Phase 1b clinical trial for moderately to severely active ulcerative colitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New Hope Research DevelopmentWhittier, CA
Meridian Clinical ResearchRockville, MD
Tandem Clinical ResearchMarrero, LA
Tandem Clinical Research, MarreroMarrero, LA
More Trial Locations
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Who Is Running the Clinical Trial?
Jiangsu Yahong Meditech Co., Ltd aka AsierisLead Sponsor
References
Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials. [2023]Current therapeutic options for patients with ulcerative colitis comprise monoclonal antibodies against tumor necrosis factor (TNF), alpha4/beta7 integrin, and interleukin (IL)12/23 as well as small molecules such as tofacitinib, upadacitinib, ozanimod, and filgotinib. However, many patients fail to respond to these agents or have loss of response over time. Therefore, there is a large unmet clinical need for new therapeutic agents.
Golimumab for moderately to severely active ulcerative colitis. [2017]Anti-TNF agents are the mainstay of therapy in patients with moderate to severe ulcerative colitis (UC) not responding to 5-aminosalisylic acid, corticosteroids, immunmodulators and for patients dependent on corticosteroids. There is a therapeutic gap of 30%- 60% with infliximab and adalimumab, which is required to be bridged by newer agents. The present review summarizes the literature on the role of golimumab, a new anti TNF agent, in ulcerative colitis.
Vedolizumab for induction and maintenance of remission in ulcerative colitis. [2018]Cellular adhesion molecules play an important role in the pathogenesis of ulcerative colitis, making selective blockade of these molecules a promising therapeutic strategy. Vedolizumab, a recombinant humanized IgG1 monoclonal antibody, inhibits adhesion and migration of leukocytes into the gastrointestinal tract by binding the alpha4beta7 integrin. Animal studies have suggested that vedolizumab may be a useful therapy for ulcerative colitis. This updated systematic review summarizes the current evidence on the use of vedolizumab for induction and maintenance of remission in ulcerative colitis.
The biologics of ulcerative colitis. [2018]Tumor necrosis factor α inhibitors dramatically changed the management of moderate-to-severe phenotypes of ulcerative colitis. The recent incoming of vedolizumab, which targets gut-specific leukocyte trafficking, provides a new biologic option for these patients. Areas covered: This review focuses on the rationale of use, efficacy, and safety profile of all biologics currently approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of ulcerative colitis, including tumor necrosis factor α inhibitors (Infliximab and biosimilars, adalimumab, and golimumab), and the more recent vedolizumab. Expert opinion: Although biologics have been available in clinical practice for ulcerative colitis for about 15 years, there are several aspects that have not been fully understood yet: we know that they work, but we still don't know which subsets of patients benefit more, and how to optimize their use. All these unresolved problems are at least partly due to the discrepancy observed between phase II/III clinical trials of all biologics currently used in ulcerative colitis and in clinical practice.
Clinical outcome of adalimumab therapy in patients with ulcerative colitis previously treated with infliximab: a Danish single-center cohort study. [2019]TNF inhibitors are effective in the treatment of ulcerative colitis. Adalimumab (ADL), a fully human TNF inhibitor, is increasingly used both as primary anti-TNF agent and in patients switching from another TNF inhibitor due to treatment failure or side effects. This study investigated clinical outcomes of ADL therapy in a clinical setting where infliximab (IFX) had been used as first choice of anti-TNF agent, and followed by ADL as second line agent.