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ATX-MS-1467

Phase 2

Multiple Sclerosis | Small molecule | Neurology |Merck KGaA|Last Updated: Jul 2, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

ATX-MS-1467 · 1 trial · 1 indication

Phase 2 1
NCT01973491ATX-MS-1467 in Multiple SclerosisMultiple Sclerosis
COMPLETED37 Analytics
PHASE2COMPLETED
ATX-MS-1467 in Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans
Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)

T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.

Secondary Endpoints

Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)
Weeks 12, 16, 20, 24, 28 and 36
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36
Baseline (Weeks -8, -4, 0), Week 12, 16, 20, 24, 28 and 36
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ATX-MS-1467EXPERIMENTAL -

Interventions

NameTypeDescription
ATX-MS-1467DRUGSubjects will receive ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female out-patients aged 18 to 65 years of age inclusive at the time of informed consent * Willing and able to provide written informed consent and to comply with the requirements of the protocol assessments/procedures * Relapsing MS (relapsing-remitting multiple scler...

Countries:Germany
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Frequently asked questions about ATX-MS-1467

What is ATX-MS-1467 used for?

ATX-MS-1467 is an investigational small molecule being developed for the treatment of multiple sclerosis. It is currently in Phase 2 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients.

Who makes ATX-MS-1467?

ATX-MS-1467 is being developed by Merck KGaA, a multinational pharmaceutical company. The company's stock is traded under the ticker symbol MKGAF. Merck KGaA is conducting clinical trials to evaluate the drug's potential in treating multiple sclerosis.

What phase is ATX-MS-1467 in?

ATX-MS-1467 is in Phase 2 clinical development for multiple sclerosis. It is an investigational drug, meaning it has not been approved by regulatory agencies. The drug is still undergoing clinical trials to assess its safety and effectiveness in patients with this condition.

What clinical trials is ATX-MS-1467 in?

ATX-MS-1467 has been studied in a Phase 2 clinical trial with the identifier NCT01973491, titled 'ATX-MS-1467 in Multiple Sclerosis'. This trial was completed and enrolled 37 participants in Germany. The study was not randomized, double-blinded, or controlled, and did not use a biomarker for patient selection.

Is ATX-MS-1467 FDA approved?

ATX-MS-1467 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for multiple sclerosis. The drug has not completed the clinical trial process required for regulatory approval, and its safety and efficacy have not been established for commercial use.