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B. Infantis 35624

Phase 1

Psoriasis | Unknown | Dermatology |Smith & Nephew SNATS, Inc.|Last Updated: Oct 13, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

B. Infantis 35624 · 1 trial · 1 indication

Phase 1 1
NCT01451346Study in Patients With Mild to Moderate PsoriasisPsoriasis
COMPLETED47 Analytics
PHASE1COMPLETED
Study in Patients With Mild to Moderate Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in the Psoriasis area and severity index between baseline and end of feeding
At 12 weeks

The PASI score stands for Psoriasis Area and Severity Index. This tool allows researchers to put an objective number on what would otherwise be a very subjective idea: how bad is a person's psoriasis. To make up the score, the three features of a psoriatic plaque (redness) scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. Then the extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72

Secondary Endpoints

Psoriasis Disability Index[PDI}
at 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo sachets contained 5 grams of Maltodextrin only.
B Infantis 35624EXPERIMENTALEach 5gram freeze-dried powder contained ≥1\*1010 Colony forming units (CFU) of B. infantis 35624/sachet.

Interventions

NameTypeDescription
B. Infantis 35624DIETARY_SUPPLEMENTOne sachet daily for 12 weeks
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects diagnosed with mild to moderate psoriasis as defined by the clinician, * Has a Psoriasis Area and Severity Index{PASI} of less than 20, * Male or female subjects, * Aged between 18-60 years of age, * Non-pregnant female and must agree to use adequate method of contrac...

Countries:Ireland
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Frequently asked questions about B. Infantis 35624

What is B. Infantis 35624 used for?

B. Infantis 35624 is an investigational therapy being studied for the treatment of mild to moderate psoriasis. It is currently in Phase 1 clinical development, and it has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial involving patients with psoriasis.

Who makes B. Infantis 35624?

B. Infantis 35624 is being developed by Smith & Nephew SNATS, Inc., a company listed on the stock exchange under the ticker symbol SNN. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for psoriasis.

What phase is B. Infantis 35624 in?

B. Infantis 35624 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of psoriasis.

What clinical trials is B. Infantis 35624 in?

B. Infantis 35624 has one completed clinical trial, identified as NCT01451346, titled "Study in Patients With Mild to Moderate Psoriasis." This Phase 1 trial enrolled 47 participants in Ireland and was a randomized, double-blind, placebo-controlled study. The trial included patients aged 18 years and older.

Is B. Infantis 35624 FDA approved?

B. Infantis 35624 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for psoriasis. The drug has completed one clinical trial, but it has not received regulatory approval for any indication.