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MRrhTSH

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

MRrhTSH · 1 trial · 1 indication

Phase 2 1
NCT00454220Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular GoiterMultinodular Goiter
COMPLETED96 Analytics
PHASE2COMPLETED
Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular Goiter
Multinodular Goiter
NCT0045422096
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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 to 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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Frequently asked questions about MRrhTSH

What is MRrhTSH used for?

MRrhTSH is an investigational small molecule being developed for the treatment of multinodular goiter, a condition characterized by an enlarged thyroid gland with multiple nodules. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes MRrhTSH?

MRrhTSH is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 2 clinical trials for the treatment of multinodular goiter.

What phase is MRrhTSH in?

MRrhTSH is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of multinodular goiter, and its safety and efficacy have not yet been established.

What clinical trials is MRrhTSH in?

MRrhTSH has one completed Phase 2 clinical trial, identified by the identifier NCT00454220. This trial was a randomized, placebo-controlled study that enrolled 96 participants with multinodular goiter. The trial was conducted in the United States, Brazil, Canada, Denmark, France, Germany, Italy, and the Netherlands.

Is MRrhTSH FDA approved?

MRrhTSH is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of multinodular goiter. The drug has completed one clinical trial, but it has not yet received regulatory approval for any indication.