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XP23829

Phase 2

Psoriasis | Small molecule | Dermatology |Dr. Reddy's Laboratories Ltd|Last Updated: Apr 12, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

XP23829 · 1 trial · 1 indication

Phase 2 1
NCT02173301A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type PsoriasisPsoriasis
COMPLETED200 Analytics
PHASE2COMPLETED
A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

• The Percent Change in PASI (Psoriasis Area and Severity Index) Score From Baseline
12 Weeks

The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0-4 scale) and is weighted by the area of involvement. The minimum possible score on this scale is '0', while the maximum score on this scale is 72. A lower score on this scale at the end of the study indicates an improvement in the condition of subject.

Secondary Endpoints

• Proportion of Subjects Who Achieve a Reduction of 75% or Greater From Baseline in PASI (PASI-75)
Weeks 2, 4, 8, 12, 14 and 16
• Proportion of Subjects Who Achieve a sPGA (Static Physician's Global Assessment) Score of Clear or Almost Clear
Weeks 2, 4, 8, 12, 14 and 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XP23829 400 mg QD (once daily)EXPERIMENTALAfter 4-week screening period, eligible subjects will be randomized to XP23829 400 mg QD for 12 weeks including titration period
XP23829 800 mg QDEXPERIMENTALAfter 4-week screening period, eligible subjects will be randomized to XP23829 800 mg QD for 12 weeks including titration period
XP23829 400 mg BID (twice daily)EXPERIMENTALAfter 4-week screening period, eligible subjects will be randomized to XP23829 400 mg BID for 12 weeks including titration period
PlaceboPLACEBO_COMPARATORAfter 4-week screening period, eligible subjects will be randomized to Placebo for 12 weeks

Interventions

NameTypeDescription
XP23829 400 mg QDDRUGactive dose 1
XP 23829 800 mg QDDRUGactive dose 2
XP23829 400 mg BIDDRUGactive dose 3
PlaceboDRUGcontrol
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Eligibility Criteria

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

Inclusion Criteria: 1. Male and female subjects, age ≥ 18. 2. Stable, moderate-to-severe plaque-type psoriasis diagnosed for at least 6 months prior to randomization (no morphology changes or significant flares of disease activity in the last 6 months in the opinion of the investigator). 3. Severit...

Countries:United States
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Frequently asked questions about XP23829

What is XP23829 used for?

XP23829 is an investigational small molecule being studied for the treatment of moderate-to-severe chronic plaque-type psoriasis. It is a dermatology asset in Phase 2 clinical development, evaluated in a randomized, double-blind, placebo-controlled trial in the United States.

Who makes XP23829?

XP23829 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical research on this small molecule for psoriasis.

What phase is XP23829 in?

XP23829 is in Phase 2 clinical development. It is an investigational drug, not yet approved, and has completed one Phase 2 trial. The study assessed its efficacy and safety in patients with moderate-to-severe chronic plaque-type psoriasis.

What clinical trials is XP23829 in?

XP23829 has one completed clinical trial, identified as NCT02173301, titled 'A Study to Assess the Efficacy and Safety of XP23829 in Subjects With Moderate-to-Severe Chronic Plaque-Type Psoriasis'. This Phase 2 study enrolled 200 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is XP23829 FDA approved?

XP23829 is not FDA approved. It is an investigational small molecule currently in Phase 2 clinical development for psoriasis. The drug has completed a Phase 2 trial, but it remains under study and has not received regulatory approval.