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ACT-128800 Dose 1

Phase 2

Multiple Sclerosis | Small molecule | Neurology |Johnson & Johnson|Last Updated: Mar 30, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment464

FDA Designations

No designations recorded

Clinical trial landscape

ACT-128800 Dose 1 · 1 trial · 1 indication

Phase 2 1
NCT01006265Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple SclerosisMultiple Sclerosis
COMPLETED464 Analytics
PHASE2COMPLETED
Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Cumulative Number of New T1 Gadolinium-Enhancing (Gd+) Lesions on Magnetic Resonance Imaging (MRI) Scan From Week 12 to Week 24
From Week 12 to 24

Cumulative Number of new T1 gadolinium-enhancing (Gd+) lesions per year on magnetic resonance imaging (MRI) scan from Week 12 to Week 24 were reported. Negative binomial (NB) regression analysis on Per protocol analysis set and imputation was applied for the missing data. Here, MS signifies multiple sclerosis.

Secondary Endpoints

Annualized Confirmed Relapse Rate
Up to 24 weeks
Number of Participants With First Confirmed Relapse as Assessed by Kaplan-Meier Estimate From Baseline to Week 24
Baseline to Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ACT-128800 Dose 1EXPERIMENTALACT-128800 Dose 1
ACT-128800 Dose 2EXPERIMENTALACT-128800 Dose 2
ACT-128800 Dose 3EXPERIMENTALACT-128800 Dose 3
PlaceboPLACEBO_COMPARATORMatching placebo

Interventions

NameTypeDescription
ACT-128800 Dose 1DRUGACT-128800 (Dose 1) administered orally once daily
PlaceboDRUGMatching placebo administered orally once daily
ACT-128800 Dose 2DRUGACT-128800 (Dose 2) administered orally once daily
ACT-128800 Dose 3DRUGACT-128800 (Dose 3) administered orally once daily
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites115

Inclusion Criteria: * Adult males and females * Diagnosis of RRMS as defined by the revised (2005) McDonald Diagnostic Criteria for Multiple Sclerosis (MS). * Signed inform consent prior to initiation of any study-mandated procedure. Exclusion Criteria: * A diagnosis of MS categorized as primary ...

Countries:United StatesAustraliaAustriaBelgiumBulgariaCanadaCzechiaFinlandFranceGermanyHungaryIsraelItalyNetherlandsPolandRomaniaRussiaSerbiaSpainSwedenSwitzerlandUkraineUnited Kingdom
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Frequently asked questions about ACT-128800 Dose 1

What is ACT-128800 Dose 1 used for in Multiple Sclerosis?

ACT-128800 Dose 1 is an investigational small molecule being studied for the treatment of relapsing-remitting multiple sclerosis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy, safety, and tolerability in patients with this condition.

What does ACT-128800 Dose 1 target?

ACT-128800 Dose 1 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential to treat relapsing-remitting multiple sclerosis, though the exact mechanism of action is not publicly detailed.

Who makes ACT-128800 Dose 1?

ACT-128800 Dose 1 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with relapsing-remitting multiple sclerosis.

What phase is ACT-128800 Dose 1 in?

ACT-128800 Dose 1 is in Phase 2 clinical development. It is an investigational drug and has not received approval from regulatory agencies. The Phase 2 trial has been completed, and the drug is not currently in active clinical trials, according to available data.

What clinical trials is ACT-128800 Dose 1 in?

ACT-128800 Dose 1 has been studied in one completed Phase 2 clinical trial with the identifier NCT01006265. This randomized, double-blind, placebo-controlled study enrolled 464 participants with relapsing-remitting multiple sclerosis across multiple countries, including the United States, Canada, and European nations.

Is ACT-128800 Dose 1 the same as ACT-128800?

ACT-128800 Dose 1 is a specific dose level of the drug ACT-128800. The clinical trial NCT01006265 evaluated the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis, with ACT-128800 Dose 1 representing one of the doses tested in the study.