Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07239336 · ClinicalTrials.gov registry record · Phase 2
Study of DONQ52 in Active Celiac Disease
A Phase 2 study of Celiac Disease, sponsored by Chugai Pharmaceutical.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
- 11
- Study locations
NCT07239336: Recruiting Phase 2 study of Celiac Disease, sponsored by Chugai Pharmaceutical.
NCT07239336 is a Phase 2 study of Celiac Disease that is actively recruiting participants, run by Chugai Pharmaceutical. The registered enrollment target is 92 participants, below the 1,976-participant average among 24 other Celiac Disease trials with a reported enrollment target (95% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07239336, a Phase 2 study of Celiac Disease, is actively recruiting participants, sponsored by Chugai Pharmaceutical.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
- 11
- Study locations
Study Summary
The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.
Primary Outcome
The Vh:Cd ratio represents mucosal architectural changes and a lower Vh:Cd ratio indicates more severe intestinal injury characterized by a flattening of the mucosa. The difference in the adjusted mean change from baseline (Run-in) to Week 27 in Vh:Cd between DONQ52 and placebo groups will be estimated using the analysis of covariance (ANCOVA) method. A negative change from baseline indicates worsening disease.
Conditions Studied
Interventions
- DRUG Placebo DONQ52
- DIETARY_SUPPLEMENT Simulated Inadvertent Gluten Exposure (SIGE) capsule
- DRUG DONQ52
Study Locations (11)
Florida
- Novum Clinical Research - Clermont
- Wellness Clinical Research - Miami Lakes
- Guardian Angel Research Center - Tampa
Arizona
- Chandler Clinical Trials - Chandler
- Scottsdale Clinical Trials - Scottsdale
Colorado
- Associates in Gastroenterology, PC - Colorado Springs
Connecticut
- Stamford Therapeutics Consortium - Stamford
Maine
- Portland Gastroenterology Center - Portland
Ohio
- Great Lakes Gastroenterology Research, LLC - Mentor
Pennsylvania
- Susquehanna Research Group, LLC - Harrisburg
Texas
- Vitality Clinical Research - Katy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2025-12-16 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 2 |
What NCT07239336 shows while recruiting
NCT07239336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,976-participant average among 24 other Celiac Disease trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo DONQ52 is the first listed.
NCT07239336 lists 11 locations in 8 states (Florida, Arizona, Colorado).
Frequently Asked Questions
What is clinical trial NCT07239336 about?
NCT07239336 is a clinical study titled "Study of DONQ52 in Active Celiac Disease". The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.
What is the current status of trial NCT07239336?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2025-12-16. Estimated completion is 2027-12-15.
What conditions does trial NCT07239336 study?
This clinical trial studies the following conditions: Celiac Disease.
What interventions are being tested in trial NCT07239336?
The interventions under investigation include: Placebo DONQ52 (DRUG), Simulated Inadvertent Gluten Exposure (SIGE) capsule (DIETARY_SUPPLEMENT), DONQ52 (DRUG).
Who is sponsoring clinical trial NCT07239336?
This trial is sponsored by Chugai Pharmaceutical, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07239336 being conducted?
This trial has 11 study locations across Arizona, Colorado, Connecticut, Florida, Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Celiac Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07239336's enrollment target sits among peer trials
92 13th of 24 higher than 12 of 24 other Celiac Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Celiac Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission
RECRUITING · Phase 2
-
A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
RECRUITING · Phase 2
-
A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
COMPLETED · Phase 2
-
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
COMPLETED · Phase 2
-
Tissue Destruction and Healing in Celiac Disease
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03184545 · 92 participants · Phase 3
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
- NCT04172532 · 92 participants · Phase 1
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
- NCT04508088 · 92 participants
Skeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease
- NCT04840602 · 92 participants · Phase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI