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CLS12311 low

Phase 1

Relapsing-remitting Multiple Sclerosis (RRMS) | Small molecule | Neurology |Novartis AG|Last Updated: Jul 3, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

CLS12311 low · 1 trial · 1 indication

Phase 1 1
NCT06430671Peptide-coupled Red Blood Cells for the Treatment of Multiple SclerosisRelapsing-remitting Multiple Sclerosis (RRMS)
ACTIVE NOT_RECRUITING11 Analytics
PHASE1ACTIVE NOT_RECRUITING
Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis
Relapsing-remitting Multiple Sclerosis (RRMS)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-related adverse events as assessed by CTCAE v4.0 and worsening of MS [Safety of CLS12311]
on average 48 weeks

Number and severity of adverse events (AEs) and serious adverse events (SAEs) and worsening of disease measured by clinical (relapses) and imaging (number \& size of brain MRI lesions)

Secondary Endpoints

Incidence of treatment-related adverse events as assessed by CTCAE v4.0 in each dose group [Safety of CLS12311]
on average 48 weeks
Incidence of patients experiencing worsening of MS in each dose group [Safety of CLS12311]
on average 48 weeks
Incidence of patients experiencing worsening of EDSS in each dose group [Safety of CLS12311]
on average 48 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CLS12311 lowEXPERIMENTALLow dose CLS12311
CLS12311 mediumEXPERIMENTALMedium dose CLS12311
CLS12311 highEXPERIMENTALHigh dose CLS12311

Interventions

NameTypeDescription
CLS12311 lowDRUGPeptide-coupled Red Blood Cells (RBCs)
CLS12311 mediumDRUGPeptide-coupled Red Blood Cells (RBCs)
CLS12311 highDRUGPeptide-coupled Red Blood Cells (RBCs)
uncoupled RBCsDRUGautologous Red Blood Cells (RBCs)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. RRMS according to the 2017 McDonald criteria 2. Male or female patients (assigned at birth) aged 18-55 years inclusive 3. Disease duration (since diagnosis) \<10 years 4. Expanded Disability Status Scale (EDSS) at baseline 0-5.5 5. Untreated patients or patients being off the...

Countries:CzechiaGermanyItalySwitzerland
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Frequently asked questions about CLS12311 low

What is CLS12311 low used for?

CLS12311 low is an investigational small molecule being developed for the treatment of relapsing-remitting multiple sclerosis (RRMS). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with RRMS to evaluate its safety and potential therapeutic effects.

Who makes CLS12311 low?

CLS12311 low is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical research on this investigational drug for the treatment of relapsing-remitting multiple sclerosis.

What phase is CLS12311 low in?

CLS12311 low is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in an early-stage clinical trial to assess its safety, tolerability, and preliminary efficacy in patients with relapsing-remitting multiple sclerosis.

What clinical trials is CLS12311 low in?

CLS12311 low is being evaluated in a Phase 1 clinical trial with the identifier NCT06430671, titled 'Peptide-coupled Red Blood Cells for the Treatment of Multiple Sclerosis.' This active, non-recruiting study has an enrollment of 11 participants and is being conducted in Czechia, Germany, Italy, and Switzerland.

Is CLS12311 low the same as CLS12311?

CLS12311 low is a specific formulation or dosage strength of the investigational drug CLS12311. Both are being developed by Novartis AG for the treatment of relapsing-remitting multiple sclerosis. The 'low' designation indicates a lower dose or concentration of the active compound being studied in clinical trials.