A Phase II, Multicenter, Double-blind, Double-dummy, Placebo Controlled, Randomized Study to Evaluate the Efficacy and Safety of AUR101 in Patients With Moderate-to-Severe Psoriasis (INDUS-3)
Overview
- Phase
- Phase 2
- Intervention
- AUR101
- Conditions
- Plaque Psoriasis
- Sponsor
- Aurigene Discovery Technologies Limited
- Enrollment
- 141
- Locations
- 25
- Primary Endpoint
- Proportion of patients achieving PASI 75 response (i.e. 75 percent reduction from baseline PASI [Psoriasis Area and Severity Index] score) at the end of week 12.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A Phase II, Multicenter, Double-blind, Double-dummy, Placebo controlled, Randomized Study to Evaluate the Efficacy and Safety of AUR101 in patients with Moderate-to-Severe Psoriasis (INDUS-3)
Detailed Description
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate the efficacy and safety of AUR101 in patients with moderate-to-severe psoriasis. Approximately 128 patients with chronic moderate-to-severe plaque psoriasis (defined as Psoriasis Area and Severity Index (PASI) ≥12 and Body Surface Area (BSA) involved ≥10%) will be randomized to four groups (three dose groups of AUR101 and one placebo group) in the ratio of 1:1:1:1. The patients in each arm will receive AUR101 of 200 mg twice daily, 400 mg twice daily, 400 mg once daily or matching placebo for 16 weeks in a double blind, double dummy fashion. All patients will be followed up for 14 ± 2 days of their last dose for safety assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before screening
- •Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 % at screening and Day 1
- •Static 5-point IGA modified \[mod\] 2011 scale of 3 or higher at screening and Day 1
- •Adult males or females, ≥ 18 to ≤ 70 years of age
- •Ability to communicate well with the investigator and to comply with the requirements of the entire study
- •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
- •History of erythrodermic, guttate or pustular psoriasis within last 12 months
- •BMI \< 18 or \> 40
- •History of lack of response to ustekinumab, secukinumab or ixekizumab (or any therapeutic agent targeted to IL12, IL-17 or IL-23) at approved doses after at least 3 months of therapy
- •Current treatment or history of treatment for psoriasis with any investigational or approved IL-17, IL-12 or IL-23 antagonist biological agents (e.g. secukinumab, briakinumab, tildrakizumab, ustekinumab etc.) within 6 months prior to the first administration of study drug.
- •Current treatment or history of treatment for psoriasis with other investigational or approved biological agents (e.g. anti-TNFα inhibitors - adalimumab, etanercept, infliximab, alefacept etc.) within 3 months prior to the first administration of study drug
- •Current treatment or history of treatment for psoriasis with non-biological systemic medications or immunomodulators (including systemic steroids, apremilast, methotrexate, cyclosporine, acitretin, etc.) or phototherapy within 4 weeks prior to the first administration of study drug.
- •Treatment with medicated topical agents (having active pharmaceutical ingredient that can impact or interfere with the effect of the study drug) within 2 weeks prior to the first administration of study drug.
- •Evidence of organ dysfunction (e.g. liver dysfunction ≥ 1.5 X of ULN for ALT, AST or ALP or Total Bilirubin, or renal dysfunction of ≥ 1.5X of ULN of serum creatinine)
- •Any surgery requiring general anesthesia within 3 months prior to screening
- •History of malignancy within last 5 years except patients with non-melanoma skin cancer or carcinoma in situ of cervix who can participate in the study. Adequately treated cutaneous basal or squamous cell carcinoma are allowed.
Arms & Interventions
AUR101 400 mg PO BID
Patients will receive AUR101 / placebo in double blind, double dummy manner
Intervention: AUR101
AUR101 200 mg PO BID
Patients will receive AUR101 / placebo in double blind, double dummy manner
Intervention: AUR101
AUR101 400 mg PO QD
Patients will receive AUR101 / placebo in double blind, double dummy manner
Intervention: AUR101
Placebo
Patients will receive AUR101 / placebo in double blind, double dummy manner
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of patients achieving PASI 75 response (i.e. 75 percent reduction from baseline PASI [Psoriasis Area and Severity Index] score) at the end of week 12.
Time Frame: Week 12
PASI-75; A higher proportion of patients reaching PASI-75 means betterment in higher proportion of patients
Secondary Outcomes
- Proportion of patients achieving DLQI score of 0 or 1 at week 12(Week 12)
- Proportion of patients achieving IGA 0 or 1 at week 12(Week 12)
- Nature and incidence of Treatment Emergent Adverse Events (TEAEs)(From Day 1 through Follow Up Visit at Week 14)
- Changes in Blood Pressure(From Day 1 through Follow Up Visit at Week 14)
- Plasma Pharmacokinetic parameters at week 4(Week 4)
- Changes in Pulse Rate(From Day 1 through Follow Up Visit at Week 14)
- Changes in Temperature(From Day 1 through Follow Up Visit at Week 14)
- Changes in Respiratory Rate(From Day 1 through Follow Up Visit at Week 14)
- Proportion of patients achieving PASI 50, PASI 90 and PASI 100 response at week 12.(Week 12)
- Proportion of patients achieving PASI 75 response (i.e. 75 percent reduction from baseline PASI [Psoriasis Area and Severity Index] score) at the end of week 4 and 8(Week 4 and Week 8)
- Percent change from baseline in PASI score at week 12(Week 12)
- Percent change from baseline to week 12 in percent BSA involved(Week 12)
- Changes in QRS interval in ECG (Electro Cardio Gram)(Week 14 (Follow Up Visit))
- Changes in QTc interval in ECG (Electro Cardio Gram)(Week 14 (Follow Up Visit))
- Changes in CBC (Complete Blood Count)(From Day 1 through Follow Up Visit at Week 14)
- Changes in Liver Function Tests(From Day 1 through Follow Up Visit at Week 14)
- Changes in PR interval in ECG (Electro Cardio Gram)(Week 14 (Follow Up Visit))
- Changes in weight(From Day 1 through Follow Up Visit at Week 14)