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colecalciferol

Phase 3

Multiple Sclerosis | Small molecule | Other |Bayer AG|Last Updated: Sep 13, 2011

Development status

Highest phase Phase 3 run by University of Zurich (NCT02419105)
Phase scored for BAYRYPhase 2
Registered trials 2 across 2 sponsors since Sep 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

colecalciferol · 1 trial · 1 indication

Phase 2 1
NCT01432704Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)Multiple Sclerosis
COMPLETED70 Analytics
PHASE2COMPLETED
Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS)
Multiple Sclerosis
NCT0143270470
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Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of add-on -treatment with colecalciferol of MS patients treated with interferon beta-1b and
one year

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

To estimate the effect of interferon-beta-1b with an add-on of colecalciferol versus interferon-beta-1b with an add-on of placebo on MRI T2 BOD at 12 months in comparison with MRI T2 BOD at baseline
12 months

Secondary Endpoints

Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation
12 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placebo capsulesPLACEBO_COMPARATORIdentically appearing placebo capsules not containing colecalciferol
colecalciferol capsulesACTIVE_COMPARATOROnce weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months

Interventions

NameTypeDescription
colecalciferolDRUGOnce weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) that contain 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * RRMS EDSS 0-5 * Betaferon used for at lest one month with positive MxA-response Exclusion Criteria: * hypercalcaemia * kidney stones * uncontrolled hypertension * hypothyreosis * peanut allergy * severe depression * sarcoidosis * use of other IMD than interferon-beta

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Competitive Landscape -Multiple Sclerosis 94 trials

Top 15 of 16 competitors

CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY6PHASE3Frexalimab, Tolebrutinib, Teriflunomide
Bristol-Myers Squibb CompanyBMY8PHASE3Ozanimod, BMS-986368, Zolacabtagene autoleucel
Novartis AG Sponsored ADRNVS23PHASE3Remibrutinib, Fingolimod, Ofatumumab, Siponimod, Rapcabtagene autoleucel
Biogen Inc.BIIB6PHASE3BIIB017, Interferon beta type 1a, Diroximel fumarate, Dimethyl fumarate, Interferon-beta
Zenas BioPharma, Inc.ZBIO3PHASE3Orelabrutinib, Obexelimab
TG Therapeutics, Inc.TGTX8PHASE3Ublituximab
Immunic, Inc.IMUX3PHASE3IMU-838
Amgen Inc.AMGN1PHASE3ABP 692
Moderna, Inc.MRNA1PHASE2mRNA-1195
Kyverna Therapeutics, Inc.KYTX3PHASE2KYV-101
Hoffmann-La RocheRHHBY1PHASE3Ocrelizumab
Tiziana Life Sciences Ltd.TLSA2PHASE2Foralumab
AstraZeneca PLCAZN1PHASE1AZD0120
Gilead Sciences, Inc.GILD1PHASE1KITE-363
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE1obe-cel (AUTO1)
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