ABX464 for Colitis, Ulcerative

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Gomel Regional Clinical Hospital, Gomel, Belarus
Colitis, Ulcerative+3 More
ABX464 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called ABX464 can help people with ulcerative colitis.

See full description

Eligible Conditions

  • Colitis, Ulcerative
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Colitis, Ulcerative

Study Objectives

This trial is evaluating whether ABX464 will improve 1 primary outcome and 13 secondary outcomes in patients with Colitis, Ulcerative. Measurement will happen over the course of From baseline to week 48.

Week 48
Glucocorticoid-free clinical remission
Week 52
Incidence and description of Adverse Events
Week 96
Change in Modified Mayo Score and in partial Modified Mayo Score
Week 48
miRNA-124 expression
Week 48
Fecal calprotectin and C-Reactive Proteine
Inflammatory Bowel Disease Questionnaire
Week 48
Clinical response at week 48
Week 96
Rectal bleeding
week 48
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Gebeos score
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on Nancy index scoring system
Histopathological evaluation of the effect of ABX464 50 mg on the rectal/sigmoidal infiltrate based on the Robarts Histological index
Proportion of patients with clinical remission at week 48 compared to baseline of induction study (ABX464-103)
weeks 48 and 96
Endoscopic changes at week 48
Sustained endoscopic changes at week 48

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Colitis, Ulcerative

Trial Design

1 Treatment Group

ABX464 50mg
1 of 1
Experimental Treatment

This trial requires 217 total participants across 1 different treatment group

This trial involves a single treatment. ABX464 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

ABX464 50mg
Drug
All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABX-464
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 48 and 96
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 48 and 96 for reporting.

Closest Location

Brandon Medical Arts Clinic - Brandon, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have completed the 16-week induction treatment period (ABX464-103);
Patients should be affiliated to a social security regimen (for French sites only);
Patients are able and willing to comply with study visits and procedures as per protocol;
Patients should understand, sign and date the written voluntary informed consent form prior to any protocol-specific procedures are performed;
Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to screening. Women must be surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or in the postmenopausal state (no menses for 12 months without an alternative medical cause) or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required.
Criteria that should be met by patients at week 48 to be eligible for 48 additional weeks of study treatment.
Patients should be in clinical response. Clinical response is defined as: a reduction in Modified Mayo Score ≥ 2 points and ≥ 30 % from baseline (induction) with an accompanying decrease in rectal bleeding sub-score ≥ 1 point or absolute rectal bleeding sub-score ≤ 1 point.
Patients able and willing to continue the study treatment and who are compliant with study visits and procedures and who signed the update of the written voluntary informed consent.

Patient Q&A Section

What causes colitis, ulcerative?

"This review suggests that smoking may be a risk factor for IBD. While there is little evidence for other potential causes, the fact that IBD is associated with environmental factors should not be forgotten." - Anonymous Online Contributor

Unverified Answer

What are common treatments for colitis, ulcerative?

"Crohn disease is commonly treated through a variety of treatments: NSAIDS, anti-inflammatory medications; steroids; and alternative treatments such as massage and herbal remedies, and electroacupuncture." - Anonymous Online Contributor

Unverified Answer

What is colitis, ulcerative?

"In many IBD patients the colon is the site of colitis and chronic inflammation. In the ulcerative colitis patients, inflammation of the colon causes diarrhea (either with or without blood in stools) and rectal bleeding.\n\nThis is the first issue of the newsletter to be published in English.\n\n- New England Journal of Medicine"" - Anonymous Online Contributor

Unverified Answer

Can colitis, ulcerative be cured?

"Colitis and ulcerative can be cured with the use of drugs or with a low-calorie diet. However, the effects remain for a limited number of patients, and treatment must be planned on the basis of individual risk factors, severity of disease, and willingness of the patient for adherence to treatment plans of extended duration." - Anonymous Online Contributor

Unverified Answer

What are the signs of colitis, ulcerative?

"Colitis can be mistaken for other gastrointestinal conditions which are characterized by watery diarrhea, abdominal pain, dehydration, and weight loss. Colitis can present with dysplasia, which manifests as a tan, yellow, or red discoloration of the stool that can be mistaken for blood. A complete workup of stool and blood is needed for diagnosis." - Anonymous Online Contributor

Unverified Answer

How many people get colitis, ulcerative a year in the United States?

"Around 2.6 million people are affected by UC each year in the United States, which comprises 4%, more than colorectal cancer. Because of the high lifetime prevalence of UC, a substantial number of affected individuals will be aged by age 20." - Anonymous Online Contributor

Unverified Answer

What does abx464 usually treat?

"Abx464 is a unique, once-in-a-lifetime therapeutic for severe active ulcerative colitis by combining it with standard colonic hygiene and anti-inflammatories. In addition such a formulation can improve the patient’s quality of life and minimize further damage in a most humane and cost-effective way." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in abx464 for therapeutic use?

"Abx464 is an orally available first-in-class, bi-functional, polypharmaceutically-modified, synthetic peptide therapeutically targeting Th1-driven inflammatory cytokine response. This novel therapeutic approach shows promising activity in a relevant model of colitis. Further proof of concept and safety will be necessary prior to starting clinical trials." - Anonymous Online Contributor

Unverified Answer

How does abx464 work?

"The efficacy of a novel small molecule compound, AUBX464, in treating colitis in mice has been demonstrated for the first time, and a new target for the treatment of inflammatory diseases, the sphingosine-1-phosphate receptor 5, was identified." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating colitis, ulcerative?

"In our opinion, patients who have not responded to treatment with standard dose drugs can be benefited from a well-thought out scheme of combined and intensive treatment." - Anonymous Online Contributor

Unverified Answer

What is the latest research for colitis, ulcerative?

"The latest news on colitis, ulcerative may help you understand about the disease. Most of colitis, ulcerative happens due to viruses. People's diet are closely correlated with colitis, ulcerative since people tend to eat high-fat, high-sugar, trans fat, low-fiber and high salt foods. These foods have the potential to cause colitis in some people. So, people will need to be careful to keep diet changes. On other hand, colitis, ulcerative can be treated. Taking medications can help to manage the disease, and the patient will feel better after the medication is taken." - Anonymous Online Contributor

Unverified Answer

Has abx464 proven to be more effective than a placebo?

"In both placebo-controlled and open-label trials the clinical superiority of BCL-354 over a placebo formulation for the treatment of active ulcerative colitis in terms of the percentage of patients who met the primary endpoints and the degree of improvement in stool indices was confirmed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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