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BCT194

Phase 1

Psoriasis | Small molecule | Dermatology |Novartis AG|Last Updated: Feb 28, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

BCT194 · 2 trials · 1 indication

Phase 1 2
NCT01539915Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic PatientsPsoriasis
COMPLETED12 Analytics
NCT00417820Study of the Safety, Tolerability and Efficacy of BCT194 in Healthy Volunteers and Patients With Psoriasis.Psoriasis
COMPLETED35 Analytics
PHASE1COMPLETED
Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic Patients
PsoriasisUnlock trial analytics
PHASE1COMPLETED
Study of the Safety, Tolerability and Efficacy of BCT194 in Healthy Volunteers and Patients With Psoriasis.
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

change in Maximum dermal interstitial concentration of BCT194
Day 1 and day 8

Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints

Area under the curve interstitial concentrations of BCT194
day 1 and day 8

Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints

Safety & tolerability
Efficacy as assessed by plaque Psoriasis Area and Severity Index (PASI) scoring at 4 weeks

Secondary Endpoints

Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)
day 1 and day 8
Change in plaque PASI scores of psoriasis lesions
day 1 and day 8
BCT194 concentrations in skin biopsies
day 1 and day 8
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Study Design & Arms

AllocationNA
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
BCT194EXPERIMENTAL -

Interventions

NameTypeDescription
BCT194DRUGTopically applied BCT194 cream (0.5%)
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Male patients and post menopausal or surgically sterile female patients aged 18 - 75 years. * Diagnosis of stable plaque psoriasis (with or without arthritis); diagnosed or history of psoriasis for at least 6 months prior to screening * Psoriatic plaques accessible for micrope...

Countries:Austria
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Frequently asked questions about BCT194

What is BCT194 used for?

BCT194 is an investigational small molecule being developed for the treatment of psoriasis. It is currently in Phase 1 clinical development, with studies conducted in patients with psoriasis to evaluate its safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics.

Who makes BCT194?

BCT194 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The company is conducting clinical trials to evaluate the drug's potential as a treatment for psoriasis.

What phase is BCT194 in?

BCT194 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 1 trials have been completed, involving a total of 47 participants with psoriasis.

What clinical trials is BCT194 in?

BCT194 has been studied in two completed Phase 1 clinical trials. The first trial, NCT00417820, enrolled 35 participants and assessed safety, tolerability, and efficacy in healthy volunteers and psoriasis patients. The second trial, NCT01539915, enrolled 12 psoriatic patients to evaluate pharmacokinetics and pharmacodynamics.

What does BCT194 target?

The specific molecular target of BCT194 has not been disclosed in the available clinical trial information. The drug is a small molecule being investigated for its effects in psoriasis, but its mechanism of action has not been publicly detailed.