Ulcerative Colitis study: ATH-063
Official title Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC)
ClinicalTrials.gov ID: NCT07513181
What this study is testing
What is ATH-063?
An investigational oral capsule being studied as a potential treatment for ulcerative colitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if ATH-063 works and is safe for people whose ulcerative colitis has not responded to advanced biologic treatments.
- Who it's for
- Adults who have moderate to severe ulcerative colitis that has not improved after biologic or advanced therapy.
- What's involved
- Participants will receive the ATH-063 treatment and attend scheduled visits and tests to monitor their condition and any side effects.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
- Male or female (assigned at birth, inclusive of all gender identities) participants 18 to 75 years of age, inclusive, at the time of informed consent.
- Male or female participants must be postmenopausal/surgically sterile, sexually abstinent, or using 2 forms of protocol-specified contraception...
- Has a diagnosis of UC confirmed by endoscopic and histologic evidence at least 4 months before screening.
- Has moderately to severely active UC, defined as a UCDSS of 5 to 9, with an EMA subscore of 2 to 3 (obtained during the central review of the...
You likely can't join if
- Clinically significant abnormal medical history, or abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening...
- Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of oral medicines (as judged by the investigator).
- Hospitalization for exacerbation of UC requiring intravenous (IV) corticosteroids (ie, UC flare) within 12 weeks prior to screening.
- Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel...
- Investigator judgment that the participant is likely to require a colectomy within 12 weeks of the start of trial medication administration.
- Has UC that is limited to the rectum or right colon.
See the full eligibility criteria
Who can join
- Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.
- Male or female (assigned at birth, inclusive of all gender identities) participants 18 to 75 years of age, inclusive, at the time of informed consent.
- Male or female participants must be postmenopausal/surgically sterile, sexually abstinent, or using 2 forms of protocol-specified contraception, including 1 physical barrier method (condom or diaphragm) plus 1 highly...
- Has a diagnosis of UC confirmed by endoscopic and histologic evidence at least 4 months before screening.
- Has moderately to severely active UC, defined as a UCDSS of 5 to 9, with an EMA subscore of 2 to 3 (obtained during the central review of the screening video endoscopy).
- Has active UC that extends \>15 cm beyond the anal verge, as identified at the screening colonoscopy.
- Has documentation of moderately to severely active UC that is refractory (inadequate response - signs and symptoms of persistently active disease despite induction treatment at the approved induction dosing indicated in...
- Has documentation of an inadequate response, loss of response, or intolerance to conventional standard-of-care therapy with corticosteroids (ie, prednisone and budesonide), 5-ASAs (ie, mesalamine, sulfasalazine), or...
- Any prior therapy, including any investigational drug, not permitted as concomitant standard-of-care therapy must have been discontinued for at least 4 weeks or 5 half-lives prior to screening, whichever is longer, or...
- Hemoglobin ≥8 g/dL
- White blood cell (WBC) ≥3×103/μL
- Neutrophil count ≥1.5×103/μL
- Platelet count ≥100,000/μL
- Serum creatinine ≤1.5 mg/dL and/or creatinine clearance \>80 mL/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values must be within 2× the upper limit of normal (ULN) for the laboratory conducting the test
- Total bilirubin ≤1.5×ULN at screening in participants who do not have Gilbert's syndrome
- Total bilirubin ≤2×ULN at screening in participants with Gilbert's syndrome
What rules you out
- Clinically significant abnormal medical history, or abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening, that the investigator judges as likely to interfere with the objectives...
- Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of oral medicines (as judged by the investigator).
- Hospitalization for exacerbation of UC requiring intravenous (IV) corticosteroids (ie, UC flare) within 12 weeks prior to screening.
- Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation.
- Investigator judgment that the participant is likely to require a colectomy within 12 weeks of the start of trial medication administration.
- Has UC that is limited to the rectum or right colon.
- Presence or history of an enteric fistula consistent with Crohn's disease (CD).
- History of ischemic colitis.
- History of indeterminate colitis or microscopic colitis.
- History of radiation colitis.
- History of CD.
- History of colonic stricture.
- Positive stool test result for Clostridioides difficile (C. difficile), bacterial infection, or ova and parasites at screening (for bacterial infections, only exclusionary if the active infection requires antibiotic...
- History or evidence of any extensive colonic resection or subtotal or total colectomy (with or without presence of a stoma or ileoanal pouch) that would prevent adequate evaluation of trial intervention on clinical...
- Current colonic adenomas, dysplasia, or past confirmed colonic dysplasia that has not been eradicated (participants who have had UC \>8 years should have had a colonoscopy to screen for dysplasia within 1 year prior to...
- Any current malignancy judged by the investigator not to be in full remission (except for basal cell and in situ squamous cell carcinomas of the skin that have been fully excised and resolved).
- Exposure to \>2 prior approved biologic/advanced UC therapies (as defined in Inclusion Criterion) when given at doses approved for the treatment of UC.
- Use of agents that deplete B or T cells (eg, rituximab) within 12 months of first trial medication administration.
- Participants with potentially active hepatitis B virus (HBV) infection or at risk of reactivation of HBV infection
- Has severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease; or signs or symptoms thereof.
- History of, or concurrent, unstable ischemic heart disease or severe congestive heart failure (New York Heart Association Class III or IV).
- History of alcohol or drug abuse or dependence within 1 year before screening that, in the opinion of the investigator, would impair the ability of the participant to comply with trial protocol requirements.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- Receiving tube feeding, defined formula diets, or total parenteral alimentation.
- History of bleeding disorders or recent use of antiplatelet or antithrombotic agents that in the investigator's judgment preclude safely performing endoscopic procedures and biopsy within the timeframe outlined in the...
- Use of drugs that are inhibitors of P-glycoprotein (P-gp; eg, amiodarone, clarithromycin, cyclosporine, ketoconazole, ritonavir, verapamil) or breast cancer resistance protein (BCRP
- Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety (including any known hypersensitivity to...
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
- Tampa, Florida, United States
- Roswell, Georgia, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States; Tampa, Florida, United States; Roswell, Georgia, United States; Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.