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ALX-0600

Phase 2

Crohn's Disease | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: May 25, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

ALX-0600 · 1 trial · 1 indication

Phase 2 1
NCT00072839Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's DiseaseCrohn's Disease
COMPLETED100 Analytics
PHASE2COMPLETED
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease
Crohn's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy variable is the percentage of subjects who respond to treatment, defined as the percentage of subjects who are in remission (CDAI less than 150) or have a 100-point or greater reduction from baseline in CDAI score at dosing Week 8.
8 weeks of treatment

Secondary Endpoints

The various secondary efficacy variables are based on the CDAI, Inflammatory Bowel Disease Questionnaire (IBDQ), plasma citrulline and laboratory inflammatory markers.
8 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORplacebo solution injected subcutaneously daily into either thigh or abdomen.
teduglutide 0.05EXPERIMENTALteduglutide 0.05 mg/kg/d injected subcutaneously daily.
teduglutide 0.1EXPERIMENTAL0.1 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen
teduglutideEXPERIMENTAL0.2 mg/kg/d teduglutide injected subcutaneously into thigh or abdomen

Interventions

NameTypeDescription
ALX-0600DRUGteduglutide
placeboDRUGplacebo solution injected subcutaneously
teduglutide 0.05DRUG0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
teduglutide 0.2 mgDRUG0.2 mg/kg/d subcutaneously injected into thigh or abdomen
Teduglutide 0.05 doseDRUG0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
teduglutide 0.1 mg doseDRUG0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria 1. Men and women, 18 years of age and older 2. Signed and dated informed consent to participate before any study-related procedures are performed 3. Diagnosis of Crohn's disease for at least 6 months that has been documented and confirmed 4. A Crohn's Disease Activity Index (CDAI...

Countries:United StatesCanada
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Frequently asked questions about ALX-0600

What is ALX-0600 used for in Crohn's Disease?

ALX-0600 is an investigational small molecule being studied for the treatment of active Crohn's Disease. It has been evaluated in a Phase 2 clinical trial to assess its safety and efficacy in patients with this condition. The drug is not approved and remains in clinical development.

Who makes ALX-0600?

ALX-0600 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical research on this investigational drug for Crohn's Disease.

What phase is ALX-0600 in?

ALX-0600 is in Phase 2 clinical development. It has completed a Phase 2 trial for active Crohn's Disease, but it is not FDA approved and remains an investigational drug.

What clinical trials is ALX-0600 in?

ALX-0600 has been studied in one completed Phase 2 clinical trial, identified as NCT00072839. This trial, titled 'Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease,' enrolled 100 participants in the United States and Canada.

Is ALX-0600 a small molecule?

Yes, ALX-0600 is a small molecule drug. It is being developed as an oral treatment for Crohn's Disease, a gastrointestinal condition. The drug is currently in Phase 2 clinical testing.