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P38 Inhibitor

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment578

FDA Designations

No designations recorded

Clinical trial landscape

P38 Inhibitor · 2 trials · 1 indication

Phase 2 2
NCT00303563A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED204 Analytics
NCT00316771A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate TherapyRheumatoid Arthritis
COMPLETED374 Analytics
PHASE2COMPLETED
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics
PHASE2COMPLETED
A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of patients with ACR 20 response
Week 12

Secondary Endpoints

Percentage of patients with ACR 50/70 response.
Week 12
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.
Throughout study
Percentage of patients with ACR 50/70 response
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4PLACEBO_COMPARATOR -
P38 Inhibitor (4) 150mgEXPERIMENTAL -
P38 Inhibitor (4) 25mgEXPERIMENTAL -
P38 Inhibitor (4) 300mgEXPERIMENTAL -
P38 Inhibitor (4) 50mgEXPERIMENTAL -
P38 Inhibitor (4) 75mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
P38 Inhibitor (4)DRUG50mg po qd
PlaceboDRUGpo qd
P38 Inhibitor (4) 150mgDRUG150mg po qd
P38 Inhibitor (4) 25mgDRUG25mg po bid
P38 Inhibitor (4) 300mgDRUG300mg po qd
P38 Inhibitor (4) 50mgDRUG50mg po qd
P38 Inhibitor (4) 75mgDRUG75mg po bid
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites61

Inclusion Criteria: * adult patients \>18 years of age, with active RA; * receiving treatment for RA on an outpatient basis; * females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the stud...

Countries:United StatesCanadaCroatiaCzechiaFranceItalyMexicoRomaniaSerbiaSouth AfricaSpainTaiwanAustraliaBrazilEstoniaGermanyGreeceIrelandNew ZealandPolandUnited Kingdom
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Frequently asked questions about P38 Inhibitor

What is P38 Inhibitor used for?

P38 Inhibitor is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is in Phase 2 clinical development and has been evaluated in patients with active rheumatoid arthritis, both as a monotherapy and in combination with stable methotrexate therapy.

Who makes P38 Inhibitor?

P38 Inhibitor is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with rheumatoid arthritis.

What phase is P38 Inhibitor in?

P38 Inhibitor is in Phase 2 clinical development for rheumatoid arthritis. Two Phase 2 trials have been completed, with a total of 578 patients enrolled. The drug is not approved and remains investigational.

What clinical trials is P38 Inhibitor in?

P38 Inhibitor has been studied in two completed Phase 2 trials: NCT00303563, a monotherapy study in 204 patients with active rheumatoid arthritis, and NCT00316771, a study in 374 patients on stable methotrexate therapy. Both trials were randomized, double-blind, and placebo-controlled.

Is P38 Inhibitor a small molecule?

Yes, P38 Inhibitor is a small molecule therapeutic being developed for rheumatoid arthritis. It is administered in clinical trials to adult patients aged 18 years and older, with both trials enrolling male and female participants.