APL-1401 for Ulcerative Colitis
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Verified Trial
Recruiting
Sponsor: Jiangsu Yahong Meditech Co., Ltd aka Asieris
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.
Do I need to stop my current medications to join the trial?The trial allows some medications if they have been stable for a certain period before joining. You can continue oral 5-ASA medications and oral corticosteroids if their doses are stable. However, you must stop certain other medications like intravenous corticosteroids, topical 5-ASA, anti-diarrheal medications, and several others for specific periods before joining. The protocol specifies different 'washout' periods for these medications, ranging from 1 to 18 weeks, depending on the drug.
Is the drug APL-1401 a promising treatment for ulcerative colitis?APL-1401 could be a promising treatment for ulcerative colitis because there is a need for new drugs that can help patients who do not respond well to current treatments. Many existing drugs do not work for everyone or lose effectiveness over time, so new options like APL-1401 are important to explore.234511
What safety data is available for APL-1401 in ulcerative colitis treatment?The provided research does not contain specific safety data for APL-1401 or its other names like Placebo, Control, or Dummy Treatment. The studies focus on the safety of other treatments such as vedolizumab, ustekinumab, and adalimumab in ulcerative colitis.7891214
What data supports the idea that APL-1401 for Ulcerative Colitis is an effective drug?The available research does not provide specific data on the effectiveness of APL-1401 for Ulcerative Colitis. Instead, it discusses other treatments like tofacitinib, which showed positive results in patients who did not respond to other drugs, and golimumab, which is used when other treatments fail. Without specific data on APL-1401, we cannot conclude its effectiveness compared to these alternatives.1461013
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.
Treatment Details
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:
πΊπΈ Approved in United States as APL-1401 for:
- None approved; currently in Phase 1b clinical trial for moderately to severely active ulcerative colitis
π¨π³ 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
The long-term outcome of ulcerative colitis treated with 6-mercaptopurine. [2017]To determine the long term outcome of ulcerative colitis in patients treated with 6-MP.
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.
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.
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.
The biologics of ulcerative colitis. [2018]Tumor necrosis factor Ξ± 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 Ξ± 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.
Short-Term Clinical Response to Corticosteroids Can Predict Long-Term Natural History of Ulcerative Colitis: Prospective Study Experience. [2022]Long-term outcome and natural history of steroid response in adult ulcerative colitis patients based on short-term response is largely unknown.
Four-year maintenance treatment with adalimumab in Japanese patients with moderately to severely active ulcerative colitis. [2019]The 52-week safety and efficacy of adalimumab in Japanese patients with moderately to severely active ulcerative colitis were demonstrated in a placebo-controlled phase 2/3 trial. Data from patients who enrolled in the open-label extension study are presented.
Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study. [2021]The efficacy and safety of vedolizumab in moderate to severely active ulcerative colitis (UC) have been demonstrated in the GEMINI 1 study (NCT00783718). This post-hoc exploratory analysis sought to establish the efficacy and safety of vedolizumab in a subgroup of patients from Asian countries with UC from GEMINI 1.
Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI). [2021]We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
Upadacitinib in refractory ulcerative colitis. [2022]We report the first clinical-practice case to date of treatment with upadacitinib for ulcerative colitis, prior refractoriness to all therapeutic options, and preventing proctocolectomy as of today after treatment for 14 months.
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.
Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. [2023]This ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three doses of vedolizumab.
Outcomes out to 12 months after sequential use of high-dose tofacitinib following infliximab in acute severe ulcerative colitis. [2023]Acute severe colitis (ASUC) remains a significant cause of morbidity in up to 25% of patients with ulcerative colitis during their disease course. We present the outcomes out to 12 months following the use of high-dose tofacitinib, 10 mg three times daily (TDS), in patients with steroid and infliximab refractory ASUC. A total of 11 patients with ASUC who were treated with high-dose tofacitinib after failing sequential infliximab therapy between 2019 and 2021 were identified at an Australian tertiary centre. Ten of 11 patients demonstrated clinical and biochemical response to treatment during admission. Two of 11 patients required colectomy, one during the index admission and the other during re-admission 10 days after the index presentation. Nine of the initial responders had a median Mayo score of 1 (IQR 0-4) at both 6 and 12 months, and all remained colectomy-free out to 12 months. Neither venous thromboembolic events nor major infective complications were observed. Tofacitinib may be a safe and effective induction and maintenance agent in the treatment of steroid and infliximab refractory ASUC. Prospective studies with long-term follow-up are required to explore the use of tofacitinib in ASUC before it can be routinely recommended as salvage therapy.
Ustekinumab as induction and maintenance therapy for ulcerative colitis - national extended follow-up and a review of the literature. [2023]Ustekinumab use in ulcerative colitis had shown low adverse event and high persistence rates to 3 years via the UNIFI long-term extension study. Outcomes beyond 3 years have not been previously described. We describe the safety signals of the entire UNIFI Australian population beyond 3 years.