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PTG-100

Phase 1

Celiac Disease | Small molecule | Gastrointestinal |Protagonist Therapeutics, Inc.|Last Updated: May 23, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

PTG-100 · 1 trial · 1 indication

Phase 1 1
NCT04524221PTG-100 for Patients With Celiac DiseaseCeliac Disease
COMPLETED12 Analytics
PHASE1COMPLETED
PTG-100 for Patients With Celiac Disease
Celiac DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage change in villous height-to crypt ratio
42 days

Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio

Secondary Endpoints

Change in celiac disease antibodies
42 days
Changes in celiac disease antibodies
42 days
CD3- positive intraepithelial lymphocyte density
42 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PTG-100EXPERIMENTALPatients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.
PlaceboPLACEBO_COMPARATORPatients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days.

Interventions

NameTypeDescription
PTG-100DRUGPTG-100, 600mg taken twice daily in capsule form for 42 days
PlaceboDRUGPlacebo taken twice daily in capsule form for 42 days
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of celiac disease Exclusion Criteria: * Active GI disease or history of clinically significant diseases * Diagnosis of Crohn's disease or ulcerative colitis.

Countries:United States
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Frequently asked questions about PTG-100

What is PTG-100 used for?

PTG-100 is an investigational small molecule being developed for the treatment of celiac disease, a gastrointestinal condition. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does PTG-100 target?

PTG-100 is a small molecule designed to target the underlying mechanisms of celiac disease. However, the specific molecular target has not been disclosed in available information.

Who makes PTG-100?

PTG-100 is being developed by Protagonist Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol PTGX.

What phase is PTG-100 in?

PTG-100 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. A Phase 1 trial has been completed.

What clinical trials is PTG-100 in?

PTG-100 has one completed Phase 1 clinical trial, identified as NCT04524221, which evaluated the drug in patients with celiac disease. The trial enrolled 12 participants in the United States.

Is PTG-100 the same as any other drug?

No alternative names for PTG-100 have been disclosed. It is referred to solely as PTG-100 in available clinical trial information.