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CTA018

Phase 2

Chronic Kidney Disease | Small molecule | Endocrine |Opko Health Inc.|Last Updated: Nov 6, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

CTA018 · 2 trials · 5 indications

Phase 2 2
NCT00742716Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney DiseaseChronic Kidney Disease
COMPLETED41 Analytics
NCT00384098Safety and Efficacy of Topically Applied CTA018 in Plaque PsoriasisPsoriasis
COMPLETED140 Analytics
PHASE2COMPLETED
Safety Study of CTA018 Injection to Treat Stage 5 Chronic Kidney Disease
Chronic Kidney DiseaseUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the single and repeat dose pharmacokinetics (PK) of CTA018 Injection
Day 1 and 12 of each dose level
To investigate the safety of CTA018 Injection
Throughout the study
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).

Secondary Endpoints

To investigate the pharmacodynamic (PD) intact parathyroid hormone (iPTH) response following CTA08 Injection
Throughout the study
To determine the efficacy of CTA018 Injection to reduce serum iPTH
Throughout the study
Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CTA018 Injection low doseEXPERIMENTALLow dose IV 3 times a week for 4 weeks
CTA018 Injection low to mid doseEXPERIMENTALlow to mid dose IV 3 times a week for 4 weeks
CTA018 Injection mid to high doseEXPERIMENTALmid to high dose IV 3 times a week for 4 weeks
CTA018 Injection high doseEXPERIMENTALhigh dose IV 3 times a week for 4 weeks

Interventions

NameTypeDescription
CTA018 InjectionDRUGComparison of different dosages of drug
CTA018 creamDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Body mass index between 18 and 35 * On maintenance hemodialysis three times per week * Serum iPTH value greater than or equal to 300 pg/mL and lower than or equal to 1000 pg/mL * Adjusted or total serum calcium value greater than or equal to 8.4 mg/dL and lower than 10.0 mg/dL...

Countries:United StatesCanada
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Frequently asked questions about CTA018

What is CTA018 used for?

CTA018 is an investigational small molecule being developed by Opko Health Inc. for chronic kidney disease and psoriasis. It has been studied in Phase 2 clinical trials for plaque psoriasis and for stage 5 chronic kidney disease with secondary hyperparathyroidism.

What does CTA018 target?

CTA018 is a small molecule developed by Opko Health Inc. Its molecular target has not been disclosed in the available information. It is being studied for chronic kidney disease and psoriasis, but its specific mechanism of action is not publicly detailed.

Who makes CTA018?

CTA018 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The company has conducted Phase 2 clinical trials for this investigational drug in chronic kidney disease and psoriasis.

What phase is CTA018 in?

CTA018 is in Phase 2 clinical development. It has completed two Phase 2 trials, one for plaque psoriasis and one for stage 5 chronic kidney disease. The drug is investigational and has not been approved by the FDA.

What clinical trials is CTA018 in?

CTA018 has completed two Phase 2 trials. NCT00384098 studied topically applied CTA018 in plaque psoriasis with 140 participants in the United States. NCT00742716 studied CTA018 injection for stage 5 chronic kidney disease with 41 participants in the United States and Canada.

Is CTA018 the same as any other drug?

CTA018 is the primary name for this investigational drug developed by Opko Health Inc. No alternative names have been reported in the available clinical trial information. It is being studied for chronic kidney disease and psoriasis.