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Study Summary
This trial tests a drug to treat ulcerative colitis, in people who haven't responded to other treatments.
Who is the study for?
This trial is for men and women at least 16 years old with moderate to severe ulcerative colitis who haven't responded well or are intolerant to certain therapies like corticosteroids, immunosuppressants, biologics, S1P receptor modulators, or JAK inhibitors. Participants must have a confirmed diagnosis of UC for over 90 days and active disease. They should agree to use effective contraception if applicable.Check my eligibility
What is being tested?
ABTECT-1 is testing the effectiveness and safety of ABX464 in doses of either 25 mg or 50 mg daily compared to a placebo in achieving clinical remission in patients with ulcerative colitis. The study randomly assigns participants to receive either ABX464 or a placebo alongside their standard treatments.See study design
What are the potential side effects?
While specific side effects for ABX464 aren't listed here, common side effects from drugs treating ulcerative colitis may include headache, nausea, fatigue, abdominal pain, and potential increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8
Secondary outcome measures
Proportion of subjects who achieve clinical response per MMS at week 8
Proportion of subjects who achieve endoscopic improvement at week 8
Proportion of subjects with HEMI per Geboes at week 8
+1 moreSide effects data
From 2019 Phase 2 trial • 32 Patients • NCT0309325917%
Abdominal pain
17%
Headache
13%
Abdominal pain upper
9%
Chest pain
9%
Influenza like illness
9%
Nausea
4%
Oropharyngeal pain
4%
Haematoma
4%
Peripheral vascular disorder
4%
Dyspnoea
4%
Dyspepsia
4%
Alopecia
4%
Rhinitis
4%
Hypophosphataemia
4%
Anorectal discomfort
4%
Nasopharyngitis
4%
Oral herpes
4%
Anal fissure
4%
Influenza
4%
Sinusitis
4%
Upper respiratory tract infection
4%
Ligament sprain
4%
AST/ALT ratio
4%
Iron deficiency
4%
Back pain
4%
Poor quality sleep
4%
Skin discolouration
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABX464
Placebo
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: ABX464 50mgExperimental Treatment1 Intervention
Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks
Group II: ABX464 25mgExperimental Treatment1 Intervention
Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks
Group III: PlaceboPlacebo Group1 Intervention
Subjects will be orally dosed daily in a fed condition (regular breakfast) in the morning with a glass of water during 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABX464
2021
Completed Phase 2
~310
Find a Location
Who is running the clinical trial?
Abivax S.A.Lead Sponsor
20 Previous Clinical Trials
3,653 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,390 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication for diarrhea.I have primary sclerosing cholangitis or autoimmune hepatitis.My ulcerative colitis affects only the very end of my colon.I have had severe colon issues, like toxic megacolon or a perforated bowel.I have been cancer-free for 5 years.I have not responded well to treatments like steroids, immunosuppressants, or biologics.I have been treated with ABX464 before.I have tried 5-ASA therapy without success.I have a history of torsade de pointes.I have a history of colon cancer or untreated polyps.I am currently taking probiotics such as Culturelle or Saccharomyces boulardii.I haven't had a live vaccine in the last 3 months and won't get one during the study.I have read, understood, and signed the consent form for this study.I was diagnosed with ulcerative colitis over 3 months ago, confirmed by a scope and tissue test.I am using or willing to use effective birth control methods.My condition is active with a score of 5 or more, including bleeding and significant endoscopy findings.I have had or will have surgery on my intestines, or I currently have a stoma.I do not have severe heart failure or uncontrolled heart disease.I am at least 16 years old, weigh over 40 kg, and have fully developed physically.I have Crohn's disease or a history of certain types of colitis.I haven't been hospitalized for a serious illness in the last 4 weeks, UC flare excluded.I do not have a history of long QT syndrome nor an abnormal QT interval.I don't have major ongoing health issues affecting my lungs, liver, pancreas, kidneys, brain, or nerves.I have not had severe infections or active hepatitis, HIV, or tuberculosis recently.
Research Study Groups:
This trial has the following groups:- Group 1: ABX464 25mg
- Group 2: ABX464 50mg
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the desired outcome of this clinical trial?
"The primary objective of this study, which will be measured over an 8-week period, is the proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8. Additionally, the study will measure secondary outcomes including the proportion of subjects who achieve endoscopic improvement at week 8 (defined as a comparison of the efficacy of ABX464 vs. placebo on endoscopic improvement), the proportion of subjects who achieve clinical response per MMS at week 8 (defined as a comparison of the efficacy of ABX464 vs. placebo on clinical response as per MMS), and finally, a comparison of the efficacy of ABX464 vs"
Answered by AI
Is this study still looking for participants?
"The clinical trial is still recruiting patients, as of 11/16/2022, according to the data posted on clinicaltrials.gov. The study was first publicized on 10/10/2022."
Answered by AI
How many guinea pigs are part of this test group?
"Yes, this is an active clinical trial that was first posted on October 10th, 2020. The study's purpose is to recruit 612 patients from 2 different sites."
Answered by AI
What have been the reported side effects of ABX464 25mg?
"ABX464 25mg has been given a safety score of 3. This is because it is a phase 3 trial, so there is both some efficacy data as well as multiple rounds of safety data supporting this estimate."
Answered by AI
Who else is applying?
What site did they apply to?
Advanced Research Institute, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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