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MRrhTSH

Phase 2

Multinodular Goiter | Small molecule | Other |Sanofi|Last Updated: Jun 7, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00454220Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular GoiterPHASE2 COMPLETED 96 — — Jul 1, 2007Jul 1, 2011Jun 7, 202211 United States, Brazil +6
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Study Endpoints
Primary Endpoints
Change from baseline to 6 months in goiter size by computer tomography (CT) scan.
Duration of core study
Extension Phase: Change in goiter size by CT scan at 36 months versus baseline, Months 6, 12 and 24
Duration of extension phase
Secondary Endpoints
Change in goiter size from baseline to 6 months in smallest cross sectional area of the trachea (SCAT).
Duration of core study
The percentage of patients in each group who attained a goiter volume shrinkage at 6 months of 28% or greater.
Core Study
Extension Phase: Change in goiter size from baseline to 6, 12, 24 and 36 months by SCAT and neck ultrasound.
Duration of extension phase
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
0.01 mg MRrhTSH + 131-I armEXPERIMENTAL -
0.03 mg MRrhTSH + 131-I armEXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboOTHER33 patients to placebo + 131-I arm
MRrhTSHDRUG33 patients to 0.01 mg MRrhTSH + 131-I arm
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Eligibility Criteria
Age Range35 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Clinical diagnosis of multinodular goiter, judged clinically and by ultrasound at Screening to be at least 40 mL, but less than or equal to 140 mL in size. * Clinically free of thyroid cancer as determined by Fine Needle Aspiration (FNA) of all dominant and/or highly suspiciou...

Countries:United StatesBrazilCanadaDenmarkFranceGermanyItalyNetherlands
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