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DONQ52 for Celiac Disease
Verified Trial
Phase 1
Recruiting
Research Sponsored by Chugai Pharmaceutical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You have been diagnosed with Celiac Disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 246 days
Awards & highlights
Study Summary
This trial is to study the safety and tolerability of an investigational drug called DONQ52 in celiac disease patients.
Who is the study for?
This trial is for people with celiac disease who have mild symptoms or are well-controlled, carry the HLA-DQ2.5 gene, and have been on a gluten-free diet for at least one year. Participants must also have a medical diagnosis confirmed by biopsies and positive serology tests. Those with refractory celiac disease or positive serology markers (tissue transglutaminase-2, deamidated gliadin peptide-IgA/G) cannot join.Check my eligibility
What is being tested?
The study is testing DONQ52's safety and how it's processed in the body in two parts: Part A gives patients one dose to see how they react, while Part B gives them multiple doses over time. The effects of DONQ52 will be compared to a placebo (a treatment without any active drug).See study design
What are the potential side effects?
Since this is an investigational drug, specific side effects of DONQ52 are not yet fully known but may include typical drug reactions such as digestive discomfort, headaches, allergic reactions or other unforeseen issues related to medication intake.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 246 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 246 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
+1 moreSecondary outcome measures
Immunogenicity
Pharmacokinetics; Area under the serum concentration time curve [AUC]
Pharmacokinetics; Half life [T1/2]
+3 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: SAD Cohort 4Experimental Treatment2 Interventions
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
Group II: SAD Cohort 3Experimental Treatment2 Interventions
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
Group III: SAD Cohort 2Experimental Treatment2 Interventions
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
Group IV: SAD Cohort 1Experimental Treatment2 Interventions
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
Group V: MAD Cohort 3Experimental Treatment2 Interventions
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
Group VI: MAD Cohort 2Experimental Treatment2 Interventions
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
Group VII: MAD Cohort 1Experimental Treatment2 Interventions
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Chugai PharmaceuticalLead Sponsor
95 Previous Clinical Trials
21,648 Total Patients Enrolled
1 Trials studying Celiac Disease
12 Patients Enrolled for Celiac Disease
Sponsor Chugai Pharmaceutical Co. LtdStudy Directorclinical-trials@chugai-pharm.co.jp
9 Previous Clinical Trials
814 Total Patients Enrolled
1 Trials studying Celiac Disease
12 Patients Enrolled for Celiac Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I only have mild symptoms of celiac disease.I have the HLA-DQ2.5 gene.I have the HLA-DQ2.5 gene.I have been diagnosed with celiac disease through tests and biopsies.You must have followed a gluten-free diet for at least 12 months.You have been on a gluten-free diet for at least 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: SAD Cohort 1
- Group 2: SAD Cohort 2
- Group 3: SAD Cohort 3
- Group 4: SAD Cohort 4
- Group 5: MAD Cohort 1
- Group 6: MAD Cohort 2
- Group 7: MAD Cohort 3
Awards:
This trial has 0 awards, including: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.
Celiac Disease Patient Testimony for trial: Trial Name: NCT05425446 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities has this research been made accessible to?
"Velocity Clinical Research in Anderson, South carolina; Jacksonville Center for Clinical Research in Florida; and Velocity Clinical Research - Boise in Idaho are the principle sites hosting this trial. Additionally there are nine other study locations."
Answered by AI
Is this experiment recruiting participants aged 55 and over?
"The eligibility criteria for this trial mandates that participants must be aged 18 or above and 65 years old or below."
Answered by AI
What are the primary goals of this clinical experiment?
"This clinical trial has a maximum duration of 246 days, and its primary outcome is to evaluate the safety of participants based on their vital signs. Secondary outcomes pertain to pharmacokinetics; these include measuring area under serum concentration curve (AUC), maximum serum concentration (Cmax) and time to maximal serum concentrations (Tmax)."
Answered by AI
To what extent is this clinical trial being participated in?
"Affirmative. According to data hosted on clinicaltrials.gov, this medical experiment has been open since September 19th 2022 and is still actively recruiting candidates. The research team needs 56 participants from a total of 9 sites."
Answered by AI
Who is eligible to partake in this medical research?
"This clinical trial seeks 56 participants who are between 18 and 65 years old, and have been diagnosed with celiac disease."
Answered by AI
Has DONQ52 received authorization from the FDA?
"DONQ52 has only been evaluated in early clinical trials, suggesting a score of 1. Consequently, there is limited information regarding its safety and efficacy."
Answered by AI
Is participation in this trial currently available to qualified individuals?
"Data on clinicaltrials.gov suggests that this trial is actively enrolling participants, and was first posted on September 19th 2022 with the latest edit occurring October 30th of the same year."
Answered by AI
Who else is applying?
What state do they live in?
Idaho
Indiana
Other
Florida
How old are they?
18 - 65
65+
What site did they apply to?
Jacksonville Center for Clinical Research
Aventiv Research, Inc.
Other
Alliance for Multispecialty Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I would like to lead a more normal life w/o always being concerned about GF foods.
PatientReceived 2+ prior treatments
Because it’s very hard for me to be on a gluten free diet. Furthermore, i realize malabsorption of key vitamins as D & B12. I.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Jacksonville Center for Clinical Research: < 48 hours
- Aventiv Research, Inc.: < 48 hours
Typically responds via
Email
Average response time
- < 2 Days
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