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CP-690-550

Phase 2

Arthritis, Rheumatoid | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Jan 3, 2013

Target and mechanism

Molecular targetJAK3, JAK1, JAK2, TYK2
Target classInhibitor
ModalitySmall molecule

Also known as tofacitinib

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment386

FDA Designations

No designations recorded

Clinical trial landscape

CP-690-550 · 1 trial · 1 indication

Phase 2 1
NCT00550446A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid ArthritisArthritis, Rheumatoid
COMPLETED386 Analytics
PHASE2COMPLETED
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
Arthritis, RheumatoidUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Week 12

ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Secondary Endpoints

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response
Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5EXPERIMENTAL -
6EXPERIMENTAL -
7PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AdalimumabDRUG40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
CP-690-550DRUG15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
CP-690,550DRUG3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
PlaceboDRUGPlacebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: * Subjects must have active rheumatoid arthritis * Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD) * Subjects must not be currently taking any DMARD other than an antimalarial Exclusion Criteria: * Subjects who discontinued any previous TNF i...

Countries:United StatesBrazilBulgariaChileCroatiaCzechiaGermanyGreeceHungaryItalyMexicoRomaniaSlovakiaSouth KoreaUkraine
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Frequently asked questions about CP-690-550

What is CP-690-550 used for?

CP-690-550, also known as tofacitinib, is an investigational small molecule being studied for the treatment of psoriasis, juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is in Phase 2 clinical development for these immunology indications.

What does CP-690-550 target?

CP-690-550 is a kinase inhibitor, belonging to the -tinib class of drugs. It targets kinases, which are enzymes involved in cell signaling pathways. By inhibiting these kinases, it modulates immune responses relevant to the autoimmune and inflammatory conditions it is being studied for.

Who makes CP-690-550?

CP-690-550 is being developed by Pfizer, Inc., a biopharmaceutical company. Pfizer is the sponsor of the clinical trials for this drug, which is also known as tofacitinib.

What phase is CP-690-550 in?

CP-690-550 is in Phase 2 clinical development for its investigational indications. It is not approved by the FDA and remains under study. The drug is being evaluated in clinical trials to assess its safety and efficacy for conditions such as rheumatoid arthritis and psoriasis.

What clinical trials is CP-690-550 in?

CP-690-550 has completed four Phase 1 clinical trials, including NCT01599377, NCT02487433, NCT04111614, and NCT04403776. These trials enrolled healthy volunteers to study bioequivalence, food effects, and pharmacokinetics of different formulations. No active trials are currently listed.

Is CP-690-550 the same as tofacitinib?

Yes, CP-690-550 is also known as tofacitinib. The drug is referred to by both names in clinical research and development contexts. Pfizer is developing this compound under the name tofacitinib.