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3 Study Matches

A PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RO7790121 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

RO7790121 will be used in the adult patients with Ulcerative colitis, to find out if it is safe and efficient in treatment of ulcerative colitis. The subjects will receive either RO7790121 drug or a placebo. After 12 weeks, the participants who complete treatment can continue to the open label treatment and receive a drug. Induction will consist of about eleven visits to the study site. The subjects will receive four intravenous treatments of either a drug or the placebo.

All subject must show understanding of the study requirements and sign the informed consent. The participants will have study procedures done, such as colonoscopy with biopsies, blood draws, and if eligible, they will be randomized at the start of induction treatment. The treatment will consists of the study drug or placebo. They will receive treatment by infusion in five study visits. After twelve weeks, the patience will be evaluated and they could continue to the open label treatment.

$75 per completed visits including endoscopy, and up to $50 for travel compensation for completed visit. You can receive a total of $1380.00 for your participation in the study.

Yes
 

Kofi Clarke
Z. Stella Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06588855
STUDY00025536
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Inclusion Criteria:
Read, understood, and provided written informed consent
Age from 18 to 80 years at the time of signing
Bodyweight more or equal than 40 kg
Confirmed diagnosis of UC
Must have had at least one of the standard treatments in the past with inadequate response, loss of response, and/or intolerance

Exclusion Criteria:
Current diagnosis of Crohn's disease (CD)
Presence of ostomy or ileoanal pouch
Diagnosis or suspicion of primary sclerosing cholangitis.
Any major surgery within 6 weeks prior to screening
Evidence of or treatment for Clostridioides difficile (C. difficile)
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
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Hershey, PA ,

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants with Moderately to Severely Active Ulcerative Colitis

The study will evaluate the safety and effectiveness of ICOTROKINRA treatment compared to placebo in participants with moderately to severely active ulcerative colitis. For the induction treatment (12 -weeks), the participants will be randomized to one of the two doses of drug icotrokinra or the placebo (2:1). At week 12 of induction, the participants will be evaluated, and clinical responders will be rerandomized to the drug treatment or placebo. Non-responders will not be randomized but could continue to the maintenance treatment (40-weeks). The study participants will have response to the treatment evaluated by blood draws to test for biomarkers and PK, study symptoms questionnaires (e.g. stool frequency and pain), and colonoscopy with biopsies. They will also have the physical evaluations, ECG, suicidality assessment, pregnancy testing and monitoring of hypersensitivity reactions, along with test for tuberculosis and other infections. The potential participants will enter screening process after they sign the informed consent. The screening for eligibility lasts six weeks and included at least two visits, the clinic visit, and the endoscopy with biopsies. If eligible for the treatment induction, five in-person visits will be held on day 0, week 2, week 4, week 8 and week 12. Except on the visit days, patients will dose at home per the team's instructions. The safety follow-up visit will be held four weeks after the last dose for eligible participants. If eligible to continue treatment after the 40-weeks of maintenance (eleven in-person visit), participants could receive treatment for another four years with in-person visits every eight weeks in the long-term extension. Endoscopy exam will be done at screening, week 12 (end of induction), week 40 (end of maintenance). or disease evaluation (ED)

Participants will be required to sign the informed consent and understand their responsibilities to participate. There will be at least two screening visits on-site. If eligible, participants will be required to attend five in-person visits during the induction treatment, comply to the instructions by the study team, have colonoscopy and blood draws done, take medication daily. They will be asked to complete daily diaries of the disease symptoms. Other tests that will be done to ensure safety are ECG, physical exams, target exams, answer questions on the topic of suicide, about tuberculosis and other infections, provide stool samples and urine pregnancy tests if applicable.

$3000

Yes
 

Kofi Clarke
Zvjezdana Stella Sever Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07196748
STUDY00027795
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Inclusion Criteria:
Adult, >18 years of age
Able to sign informed consent and understand the study requirements
Diagnosed with ulcerative colitis
Received treatment for ulcerative colitis that did not work or stopped working
Must agree to the contraception requirements

Exclusion Criteria:
Complications of UC with fulminanting colitis, toxic megacolon, anything requiring surgery
presence of stoma
presence of history of fistula
Reseaction of colon within last six months or plans for resection
Evidence of high- or low- grade dysplasia in the area of colitis, or adenomatous polyps outside of area of known colitis
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
I'm interested
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See this study on ClinicalTrials.gov
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Hershey, PA ,

SUNSCAPE-1:multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis

This is a Phase 3 study for Induction treatment of ulcerative colitis to evaluate safety and efficacy of duvakitug. The subjects are going to be enrolled in either the open label induction (Study-1), or placebo controlled induction (Study-2) across the study sites. All the participants who respond to treatment can be randomized into maintenance treatment.. The participants who do not respond to treatment will be eligible for an extended induction. The subjects must sign the informed consent before any procedures. the screening period will be for 5 weeks, and the Induction treatment will last 12 weeks. There will be six drug administrations in the induction treatment by subcutaneous injections. The participants will have in person visits, and will have procedures done such as blood draws, physical examination, endoscopy with biopsies, and completing questionnaires.

Participants will attend in person visit at the research clinical facility in Hershey, PA. If they sign the informed consent and want to participate, they will have vital checked, physical examination done. They will provide specimens such as blood and stool. They will answer questionnaires at home and in the clinic. The endoscopy will be done with biopsy to evaluate the disease response to the treatment. The drug will be administered by subcutaneous injection in the clinic. There will be a compensation for every completed visit.

$1400

Yes
 

Kofi Clarke
Zvjezdana Stella Sever Chroneos - at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
Medicine: Gastroenterology and Hepatology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT07184996
STUDY00027966
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Inclusion Criteria:
Age 18-80 years at screening
Signed informed consent
Diagnosis of ulcerative colitis (UC) at least three months
Had inadequate response to conventional treatment
Must weght at least 40 kg (88.2 lb)

Exclusion Criteria:
Diagnosis of Crohn's disease
Complications of UC (abscess, strictures, fulminating colitis or toxic megacolon)
Diagnosis of ulcerative proctitis
Current ostomy
Short bowel syndrome, or history of >3 bowel resections
Digestive Systems & Liver Disease
Experimental drug compared to a placebo/”sugar pill”
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location

Study Locations

Hide all locations
Location Contacts
Hershey, PA ,