Recent Updates
Recently added Catalysts

TEV-48574

Phase 2

Crohn Disease | Small molecule | Immunology |Teva Pharmaceutical Industries Limited|Last Updated: Mar 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment290
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05499130A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's DiseasePHASE2 COMPLETED 290Sep 30, 2022Nov 12, 2024Mar 27, 2026164 United States, Austria +17
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS
Week 14

The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".

Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD
Baseline to Week 14

The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.

Secondary Endpoints
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by the MMS
Baseline to Week 14
Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES)
Week 14
Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES
Week 14
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TEV-48574, 450 mg (UC)EXPERIMENTALAdministered by subcutaneous infusion for participants with UC
TEV-48574, 900 mg (UC)EXPERIMENTALAdministered by subcutaneous infusion for participants with UC
TEV-48574, 1800 mg (UC)EXPERIMENTALAdministered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03.
TEV-48574, 450 mg (CD)EXPERIMENTALAdministered by subcutaneous infusion for participants with CD
TEV-48574, 900 mg (CD)EXPERIMENTALAdministered by subcutaneous infusion for participants with CD
TEV-48574, 1800 mg (CD)EXPERIMENTALAdministered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03.
Placebo UCPLACEBO_COMPARATORMatching Placebo
Placebo CDPLACEBO_COMPARATORMatching Placebo
Interventions
NameTypeDescription
TEV-48574DRUGSubcutaneous infusion
PlaceboDRUGMatching Placebo
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites164

Inclusion Criteria: * Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months * The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study * The participant is able to understand the nature of ...

Countries:United StatesAustriaBelgiumBulgariaCanadaCzechiaFranceGeorgiaGermanyHungaryIsraelItalyJapanNorwayPolandSlovakiaSpainUkraineUnited Kingdom
Unlock Eligibility Criteria