Recent Updates
Recently added Catalysts

CCX282-B

Phase 2

Celiac Disease | Small molecule | Gastrointestinal |Amgen Inc.|Last Updated: Mar 6, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

CCX282-B · 3 trials · 3 indications

Phase 2 3
NCT00540657A Phase II Study of CCX282-B in Patients With Celiac DiseaseCeliac Disease
COMPLETED90 Analytics
NCT00306215A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's DiseaseCrohn's Disease
COMPLETED436 Analytics
NCT00102921Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's DiseaseCrohn Disease
COMPLETED70 Analytics
PHASE2COMPLETED
A Phase II Study of CCX282-B in Patients With Celiac Disease
Celiac DiseaseUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of CCX282-B in Subjects With Moderate to Severe Crohn's Disease
Crohn's DiseaseUnlock trial analytics
PHASE2COMPLETED
Safety and Activity Study of an Oral Medication to Treat Moderate to Severe Crohn's Disease
Crohn DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.
Percentage of subjects achieving a clinical response (defined as a decrease from baseline in Crohn's Disease Activity Index [CDAI] score of at least 70) on Day 57
Day 57
Crohn's Disease Activity Index score
Safety (Adverse Events, tolerability)

Secondary Endpoints

Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
3EXPERIMENTALBlinded study arm
4EXPERIMENTALBlinded study arm

Interventions

NameTypeDescription
CCX282-BDRUG250mg capsule, twice daily, 13 weeks
PlaceboDRUGPlacebo capsule, twice daily, 13 weeks
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Male or female, between 18 and 75 years of age * Established diagnosis of celiac disease * Subject has been following a strict gluten-free diet for at least 24 months Key Exclusion Criteria: * History of any infection requiring intravenous antibiotics, a serious local in...

Countries:FinlandAustraliaAustriaBelgiumBrazilBulgariaCanadaCzechiaDenmarkFranceGermanyHungaryIsraelNetherlandsPolandSouth AfricaSwedenUnited KingdomUnited States
Unlock Eligibility Criteria

Frequently asked questions about CCX282-B

What is CCX282-B used for?

CCX282-B is an investigational small molecule being studied for gastrointestinal conditions, including moderate to severe Crohn's disease and celiac disease. It has been evaluated in Phase 2 clinical trials for these indications.

Who makes CCX282-B?

CCX282-B is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical development.

What phase is CCX282-B in?

CCX282-B is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for Crohn's disease and celiac disease have been completed.

What clinical trials is CCX282-B in?

CCX282-B has been studied in three completed Phase 2 trials. NCT00102921 and NCT00306215 evaluated the drug in moderate to severe Crohn's disease, while NCT00540657 assessed it in celiac disease. These trials were randomized, double-blind, and placebo-controlled.

Is CCX282-B the same as other names?

CCX282-B is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available clinical trial information.