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O estudo clínico NCT07239336 para Doença Celíaca está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Chugai PharmaceuticalStudy of DONQ52 in Active Celiac Disease Fase II 92 Dieta
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07239336 procura avaliar tratamento para Doença Celíaca. Este é um estudo intervencionista de Fase II. Seu status atual é: em recrutamento. O estudo começou em 16 de dezembro de 2025 e pretende incluir 92 participantes. Coordenado por Chugai Pharmaceutical e deve ser concluído em 15 de dezembro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 12 de março de 2026.
Resumo
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.
Título oficial
A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate The Efficacy and Safety of DONQ52 in Active Celiac Disease Patients Who Have Duodenal Mucosal Damage and Persistent Symptoms Despite Attempting A Gluten-free Diet (DAISY STUDY)
Condições médicas
Doença CelíacaOutros IDs do estudo
- DQB104CT
Número NCT
Data de início (real)
2025-12-16
Última atualização postada
2026-03-12
Data de conclusão (estimada)
2027-12-15
Inscrição (estimada)
92
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Em recrutamento
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Duplo-cego
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Comparador placeboPlacebo + SIGE Gluten capsule Placebo subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally | Placebo DONQ52 Placebo DONQ52 subcutaneous injection Simulated Inadvertent Gluten Exposure (SIGE) capsule SIGE gluten capsules orally |
ExperimentalDONQ52 + SIGE Gluten capsule DONQ52 subcutaneous (SC) injection as per protocol + SIGE Gluten capsule orally | DONQ52 DONQ52 subcutaneous injection Simulated Inadvertent Gluten Exposure (SIGE) capsule SIGE gluten capsules orally |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in Villous Height to Crypt Depth Ratio (Vh:Cd) | 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. | Baseline to Week 27 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change in Average of total score of Celiac Disease Symptom Diary (CDSD) Gastrointestinal (GI) domain (abdominal pain, diarrhea, nausea, and bloating) calculated as two-week average. | CDSD symptom severity score is an average of the daily symptom severity scores during the week. The daily symptom severity score is the average of the severity score for diarrhea, abdominal pain, bloating, nausea, and tiredness ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement. | Baseline to Week 27 |
Change in Average of the total score of non-stool GI symptoms (abdominal pain, nausea, and bloating) calculated as two-week average. | CDSD GI symptom severity score is an average of the daily non-stool GI symptom severity scores during the week. The daily non-stool GI symptom severity score is the average of the severity score for abdominal pain, nausea, and bloating, ranging from 0 to 4. Symptom severity is evaluated using 5-point Likert-type scales (none, mild, moderate, severe, and very severe). Higher scores indicate more severe symptoms. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement. | Baseline to Week 27 |
Change in Average of diarrhea frequency score as assessed by CDSD frequency supplement calculated as two-week average. | Diarrhea frequency score assessed by CDSD frequency supplement is an average of the daily diarrhea frequency score during the week. Results are reported as mean change from baseline at Week 13-14 and Week 25-26. A negative change from baseline indicates improvement. | Baseline to Week 27 |
Relationship between the total score of CDSD GI domain and Patient Global Impression of Severity (PGI-S) or Patient Global Impression of Change (PGI-C). | The PGI-S is a Patient-Reported Outcome (PRO) measure assessing participant's impression of overall severity of disease symptoms. The PGI-S consists of single-item which asks participant's disease severity over the past 7 days and 14 days. It is rated on a 5-point scale from None to Very Severe. This PGI-S has been specifically modified to focus on celiac disease symptoms (i.e., abdominal pain, bloating, diarrhea, and nausea), adapting the standard PGI-S framework to be celiac disease-specific.
The PGI-C is a PRO measure assessing participant's impression of the overall change in disease symptoms. The PGI-C consists of single-item which asks the change of participant's clinical status since the start of the study. It is rated on a 7-point scale from Very Much Improved to Very Much Worse. This PGI-C has been specifically modified to focus on celiac disease symptoms (i.e., CDSD GI items), adapting the standard PGI-C framework to be celiac disease-specific. | Baseline to 47 weeks |
Incidence and severity of adverse events (AEs) and their causal relationship to the investigational medicinal products (IMPs). | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a markedly abnormal physical examination finding, vital sign value, laboratory test value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.The investigator clinically judges whether an AE was caused by the IMP. This assessment of causality, often categorized as "related" or "not related," is a distinct step performed after an event has been identified and recorded as an AE. | Baseline to 47 weeks |
Serum DONQ52 concentration. | Day1 to 47 weeks | |
Prevalence of anti-drug antibodies (ADAs) to DONQ52. | Day1 to 47 weeks | |
Incidence of anti-drug antibodies (ADAs) to DONQ52. | Day1 to 47 weeks |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Body mass index (BMI) of 18 to 40 (kg/m2) at screening.
Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.
History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD
Attempting a GFD for at least 12 months prior to the screening visit.
- The participants should be instructed not to alter dietary habits including a GFD during the study period.
Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygous or heterozygous).
Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.
Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies.
Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less
- Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.
- History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).
- History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.
- History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.
- Participants who carry the HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) genotype (homozygous or heterozygous).
- Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology.
- Helicobacter pylori tests that indicate current infection.
- Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.
- Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening.
- Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening.
- Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.
Chugai PharmaceuticalContato central do estudo
Contato: Clinical trials information, only use Email, [email protected]
11 Locais do estudo em 1 países
Arizona
Chandler Clinical Trials, Chandler, Arizona, 85224, United States
Em recrutamento
Scottsdale Clinical Trials, Scottsdale, Arizona, 85260, United States
Em recrutamento
Colorado
Associates in Gastroenterology, PC, Colorado Springs, Colorado, 80923, United States
Em recrutamento
Connecticut
Stamford Therapeutics Consortium, Stamford, Connecticut, 06905, United States
Em recrutamento
Florida
Novum Clinical Research, Clermont, Florida, 34711, United States
Em recrutamento
Wellness Clinical Research, Miami Lakes, Florida, 33016, United States
Em recrutamento
Guardian Angel Research Center, Tampa, Florida, 33614, United States
Em recrutamento
Maine
Portland Gastroenterology Center, Portland, Maine, 04101, United States
Em recrutamento
Ohio
Great Lakes Gastroenterology Research, LLC, Mentor, Ohio, 44060, United States
Em recrutamento
Pennsylvania
Susquehanna Research Group, LLC, Harrisburg, Pennsylvania, 17110, United States
Em recrutamento
Texas
Vitality Clinical Research, Katy, Texas, 77494, United States
Em recrutamento