Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: AUR-101: Two doses of AUR-101 in in approximately 90 patients with moderate-to-severe psoriasis (defined as Psoriasis Area and Severity Index (PASI) �12 and Body Surface Area (BS
Sponsors
Aurigene Discovery Technologies Limited Subsidiary of Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving PASI 75 response (i.e. 75% reduction from baseline PASI score)Timepoint: At the end of week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 (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 baseline PASI score)Timepoint: At week 4, 8 and 12.;Proportion of patients achieving PASI 75 response (i.e. 75% reduction from baseline PASI score)Timepoint: At the end of week 4 and 8. | — |
Countries
India, United States of America
Contacts
Public ContactShilendra Pandey
Aurigene Discovery Technologies Limited (Subsidiary of Dr. Reddy�s Laboratories Limited)
Outcome results
None listed