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CC10004

Phase 2

Psoriasis | Small molecule | Dermatology |Amgen Inc.|Last Updated: Apr 24, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment279

FDA Designations

No designations recorded

Clinical trial landscape

CC10004 · 2 trials · 1 indication

Phase 2 2
NCT00606450Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type PsoriasisPsoriasis
COMPLETED260 Analytics
NCT00604682Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type PsoriasisPsoriasis
COMPLETED19 Analytics
PHASE2COMPLETED
Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis
PsoriasisUnlock trial analytics
PHASE2COMPLETED
Open-Label,Single-Arm Pilot Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Preliminary Efficacy of CC1004 in Subjects With Severe Plaque Type Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

To compare the clinical efficacy of 2 oral doses of CC-10004 with placebo when taken for 12 weeks in subjects with moderate-to-severe plaque-type psoriasis
12 weeks
To evaluate the pharmacodynamic effect of orally administered CC10004 when taken for 29 days in reducing epidermal thickness in subjects with severe plaque-type psoriasis.
29 days

Secondary Endpoints

To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis
12 weeks
To evaluate the effects of CC-10004 compared to placebo on the quality of life in subjects with moderate-to-severe plaque-type psoriasis.
12 weeks
To evaluate the safety of orally administered CC10004 in subjects with severe plaque-type psoriasis during the treatment and follow up phases.
58 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
20 mg Apremilast dailyEXPERIMENTAL20 mg of CC-10004 daily
20mg Apremilast twice dailyEXPERIMENTALCC-10004 twice daily
PlaceboPLACEBO_COMPARATORPlacebo arm
Administration of CC10004EXPERIMENTAL -

Interventions

NameTypeDescription
CC-10004DRUG20 mg CC-10004 taken 1 time per day for 12 weeks
PlaceboDRUGmatching placebo taken either 1 or 2 times per day for 12 weeks
CC10004DRUG2 X 10 mg caps taken once daily for a daily dose of 20 mg. Must be taken upon awakening and fasted
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Must understand and voluntarily sign and informed consent form * Must be in good health as judged by the investigator * Must be able to adhere to the study visit schedule and other protocol requirements * Must have greater than or equal to a 6 month history of moderate-to-seve...

Countries:CanadaCzechiaGermanyUnited States
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Frequently asked questions about CC10004

What is CC10004 used for?

CC10004 is an investigational small molecule being developed for the treatment of psoriasis, specifically severe plaque type psoriasis and moderate to severe plaque type psoriasis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes CC10004?

CC10004 is being developed by Amgen Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with psoriasis.

What phase is CC10004 in?

CC10004 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both involving patients with plaque type psoriasis. The drug is investigational and has not been approved for any use, meaning it is still undergoing clinical evaluation.

What clinical trials is CC10004 in?

CC10004 has been studied in two completed Phase 2 trials. NCT00604682 was an open-label, single-arm pilot study in 19 patients with severe plaque type psoriasis in the United States. NCT00606450 was a double-blind, randomized, placebo-controlled trial in 260 patients with moderate to severe plaque type psoriasis in Canada, Czechia, and Germany.

Is CC10004 the same as apremilast?

CC10004 is also known as apremilast, a small molecule being developed by Amgen Inc. for the treatment of psoriasis. The drug has been evaluated in Phase 2 clinical trials, including a placebo-controlled study, but it remains investigational and is not yet approved.