Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients

January 29, 2025 updated by: Chugai Pharmaceutical

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)

This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Campbelltown Hospital
    • Queensland
      • Morayfield, Queensland, Australia, 4506
        • University of Sunshine Coast Clinical Trials Centre - Morayfield
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Leesburg, Florida, United States, 34748
        • Clinical Site Partners
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners - Orlando
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research - Boise
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
    • Minnesota
      • Rochester, Minnesota, United States, 55095
        • Mayo Clinic - Rochester
    • New York
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group
      • New York, New York, United States, 10019
        • Columbia University Medical center
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Lucas Research - Diabetes & Endocrinology Consultants, PC
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Clinical Research
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Aventiv Research, Inc.
      • Dayton, Ohio, United States, 45414
        • Digestive Specialists Inc
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Velocity Clinical Research, Anderson
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Alliance for Multispecialty Research
    • Texas
      • Waco, Texas, United States, 76712
        • Digestive Research of Central Texas
    • Utah
      • Ogden, Utah, United States, 84403
        • Care Access Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
  • Be on a GFD for at least 12 months
  • HLA-DQ2.5 genotype
  • Experienced at most mild symptoms of celiac disease

Exclusion Criteria:

  • Refractory celiac disease
  • Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAD Cohort 1
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
Drug: Placebo
Subcutaneous (SC) injection
Drug: DONQ52
Subcutaneous (SC) injection
Experimental: SAD Cohort 2
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
Drug: Placebo
Subcutaneous (SC) injection
Drug: DONQ52
Subcutaneous (SC) injection
Experimental: SAD Cohort 3
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
Drug: Placebo
Subcutaneous (SC) injection
Drug: DONQ52
Subcutaneous (SC) injection
Experimental: SAD Cohort 4
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
Drug: Placebo
Subcutaneous (SC) injection
Drug: DONQ52
Subcutaneous (SC) injection
Experimental: MAD Cohort 1
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
Drug: Placebo
Subcutaneous (SC) injection
Drug: DONQ52
Subcutaneous (SC) injection
Experimental: MAD Cohort 2
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
Drug: Placebo
Subcutaneous (SC) injection
Drug: DONQ52
Subcutaneous (SC) injection
Experimental: MAD Cohort 3
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
Drug: Placebo
Subcutaneous (SC) injection
Drug: DONQ52
Subcutaneous (SC) injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Time Frame: Up to 246 days
Incidence and severity of TEAEs and its relationship to the study drugs
Up to 246 days
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
Time Frame: Up to 246 days
Abnormality in vital signs
Up to 246 days
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Time Frame: Up to 246 days
Abnormality in Electrocardiograms (ECGs)
Up to 246 days
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Time Frame: Up to 246 days
Incidence of laboratory abnormalities, based on clinical laboratory tests
Up to 246 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics; Serum DONQ52 concentration
Time Frame: Up to 246 days
Serum DONQ52 concentrations over time
Up to 246 days
Pharmacokinetics; Maximum serum concentration [Cmax]
Time Frame: Up to 246 days
Cmax of DONQ52
Up to 246 days
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Time Frame: Up to 246 days
Tmax of DONQ52
Up to 246 days
Pharmacokinetics; Area under the serum concentration time curve [AUC]
Time Frame: Up to 246 days
AUC of DONQ52
Up to 246 days
Pharmacokinetics; Half life [T1/2]
Time Frame: Up to 246 days
T1/2 of DONQ52
Up to 246 days
Immunogenicity
Time Frame: Up to 246 days
Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52
Up to 246 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chugai Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sponsor Chugai Pharmaceutical Co. Ltd, clinical-trials@chugai-pharm.co.jp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DQB101US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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