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CTA018

Phase 2

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

CTA018 target and mechanism

ModalitySmall molecule

Also known as CTA018 cream, CTA018 Injection

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials2
Total Enrollment181

FDA Designations

No designations recorded

CTA018 clinical trials

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?

CTA018 is an investigational small molecule developed by Opko Health Inc. (ticker OPK) for chronic kidney disease and psoriasis. It has been studied in Phase 2 clinical trials, including one in Stage 5 chronic kidney disease and one in plaque psoriasis. It is not approved and remains in clinical development.

What is CTA018 used for in chronic kidney disease?

CTA018 has been studied in chronic kidney disease, specifically in a Phase 2 trial of CTA018 Injection to treat Stage 5 chronic kidney disease. That trial also enrolled patients with secondary hyperparathyroidism, chronic renal insufficiency, and chronic renal failure. CTA018 is investigational and has not been approved for any use.

Who makes CTA018?

CTA018 is developed by Opko Health Inc., which trades under the ticker OPK. Opko Health sponsored the Phase 2 clinical trials of CTA018 in chronic kidney disease and plaque psoriasis. No other developer or partner is identified for the program.

What phase is CTA018 in?

CTA018 is in Phase 2 development. Two Phase 2 trials have been completed: one in Stage 5 chronic kidney disease and one in plaque psoriasis. There are no active trials of CTA018, and the drug is investigational rather than approved.

What clinical trials is CTA018 in?

CTA018 has been evaluated in two completed Phase 2 trials. NCT00742716 studied CTA018 Injection in Stage 5 chronic kidney disease across the United States and Canada. NCT00384098 studied topically applied CTA018 in plaque psoriasis in the United States. Neither trial is currently active.

Is CTA018 the same as CTA018 cream or CTA018 Injection?

Yes. CTA018 cream and CTA018 Injection are alternative names for CTA018, referring to different formulations of the same investigational small molecule from Opko Health Inc. The cream formulation was studied in plaque psoriasis, while the injection formulation was studied in Stage 5 chronic kidney disease.