A Phase II clinical study being done at multiple centres on moderate to severe Psoriasis patients. This is a double-blind, double-dummy, placebo-controlled and randomized trial where two doses of the study drug (AUR101) shall be assessed for Safety and Efficacy.
- Conditions
- Health Condition 1: L400- Psoriasis vulgaris
- Registration Number
- CTRI/2020/01/022728
- Lead Sponsor
- Aurigene Discovery Technologies Limited Subsidiary of Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6
months before screening
2. Psoriasis of at least moderate severity, defined as PASI�12 and involved
BSA�10 % at screening and Day 1
3. Adult males or females, � 18 to � 65 years of age,
4. Ability to communicate well with the investigator and to comply with the
requirements of the entire study
5. Willingness to give written informed consent (prior to any study related
procedures being performed) and ability to adhere to the study restrictions and
assessments schedule.
1. History of erythrodermic, guttate, or pustular psoriasis within last 12 months
2. Efficacy failure on any biologic (e.g. interleukin (IL)-17 antibodies like
brodalumab or ixekizumab or anti-TNF agents like etanercept, infliximab or adalimumab) for the treatment of psoriasis
Note: Efficacy failure is defined as: A) Failure to achieve static Physician/
Investigator Global Assessment (PGA/IGA) of 0 to 2 (i.e. clear to mild) despite a continuous treatment with biologic at the approved (as in package insert) dose for at least 8 weeks And / Or B) After having an efficacious response, PGA/IGA increased to 3 or higher while receiving the approved (as in package insert) dose as maintenance
3. Static 5-point IGA mod 2011 scale of 0 to 2 at screening or Day 1.
4. BMI � 35 kg/m2
5. Current treatment or history of treatment for psoriasis with IL-17 or IL-12/23 antagonist biological agents (e.g. secukinumab, briakinumab, tildrakizumab, ustekinumab etc.) within 6 months prior to study day 1
6. Current treatment or history of treatment for psoriasis with other biological
agents (e.g. adalimumab, etanercept, infliximab, alefacept etc.) within 3 months
prior to study day 1
7. Current treatment or history of treatment for psoriasis with non-biological systemic medications (including systemic steroids, methotrexate, cyclosporine etc.) or phototherapy within 4 weeks prior to study day 1.
8. Treatment with medicated topical agents (having active pharmaceutical ingredient that can impact the interfere with effect of the study drug; See Section 8.11 of protocol) within 2 weeks prior to study day 1.
9. History or presence of any medical or psychiatric disease, or clinically
significant laboratory
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving PASI 75 response (i.e. 75% reduction from <br/ ><br>baseline PASI score)Timepoint: At the end of week 12.
- Secondary Outcome Measures
Name Time Method Change from baseline in IGA scaleTimepoint: At week 4, 8 and 12;Change from baseline to week 4, 8 and 12 in Dermatology Life Quality Index <br/ ><br>(DLQI)Timepoint: At week 4,8 and 12;Change from baseline to week 4, 8 and 12 in percent Body Surface Area (BSA) involvedTimepoint: At week 4, 8 and 12;Percent change from baseline in PASI scoreTimepoint: At week 4, 8 and 12;Proportion of patients achieving IGA 0 or 1Timepoint: At week 4, 8 and 12;Proportion of patients achieving PASI 50 response (i.e. 50% reduction from <br/ ><br>baseline PASI score)Timepoint: At week 4, 8 and 12.;Proportion of patients achieving PASI 75 response (i.e. 75% reduction from <br/ ><br>baseline PASI score)Timepoint: At the end of week 4 and 8.