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IONIS-DMPKRx

Phase 1

Myotonic Dystrophy Type 1 | Small molecule | Rare Disease |Ionis Pharmaceuticals, Inc.|Last Updated: Dec 6, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

IONIS-DMPKRx · 1 trial · 1 indication

Phase 1 1
NCT02312011A Safety andTolerability Study of Multiple Doses of ISIS-DMPKRx in Adults With Myotonic Dystrophy Type 1Myotonic Dystrophy Type 1
COMPLETED48 Analytics
PHASE1COMPLETED
A Safety andTolerability Study of Multiple Doses of ISIS-DMPKRx in Adults With Myotonic Dystrophy Type 1
Myotonic Dystrophy Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety (The number of participants with adverse events)
Participants will be followed for the duration of the study; an expected 24 - 32 weeks

The number of participants with adverse events

Tolerability (The number of participants with adverse events)
Participants will be followed for the duration of the study; an expected 24 -32 weeks

The number of participants with adverse events

Secondary Endpoints

Plasma Pharmacokinetics (Cmax, Tmax)
Plasma at 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hours after dosing.
Urine Pharmacokinetics (Amount of drug excreted in the urine)
0-24 hours post-dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IONIS-DMPKRxEXPERIMENTALIONIS DMPKRx is administered subcutaneously over the course of 6 weeks for dose levels 1, 2, 3, 4, and 5. IONIS DMPKRx is administered subcutaneously over the course of 12 weeks for dose levels 4 or 5.
PlaceboPLACEBO_COMPARATORA placebo is administered subcutaneously over the course of 6 weeks. A placebo is administered subcutaneously over the course of 12 weeks.

Interventions

NameTypeDescription
IONIS-DMPKRxDRUGDrug
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements 2. Males or females aged 20 to 55 years old at the time of informed consent 3. Satisfy the following: 1. Females: non...

Countries:United States
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Frequently asked questions about IONIS-DMPKRx

What is IONIS-DMPKRx used for?

IONIS-DMPKRx is an investigational drug being developed for the treatment of Myotonic Dystrophy Type 1, a rare genetic disorder. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in adult patients with this condition.

Who makes IONIS-DMPKRx?

IONIS-DMPKRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug.

What phase is IONIS-DMPKRx in?

IONIS-DMPKRx is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the safety and tolerability of multiple doses of the drug in adults with Myotonic Dystrophy Type 1. The drug remains investigational and is not yet approved.

What clinical trials is IONIS-DMPKRx in?

IONIS-DMPKRx has been studied in one clinical trial, identified as NCT02312011. This was a Phase 1, randomized, double-blind, placebo-controlled study that evaluated the safety and tolerability of multiple doses in adults with Myotonic Dystrophy Type 1. The trial enrolled 48 participants in the United States and has been completed.

Is IONIS-DMPKRx the same as ISIS-DMPKRx?

Yes, IONIS-DMPKRx is the same drug as ISIS-DMPKRx. The clinical trial NCT02312011 was originally titled as a study of ISIS-DMPKRx, reflecting the previous name of the compound. The drug is now referred to as IONIS-DMPKRx.