Status:
COMPLETED
A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)
Lead Sponsor:
Aurigene Discovery Technologies Limited
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV Ab) at screening
- Patient with known history of systemic tuberculosis or currently suspected or known to have active tuberculosis
- Patient expected to be started on anti-tubercular therapy either for treatment or prophylaxis of tuberculosis
- Suspected tuberculosis infection as evident from a positive QuantiFERON TB-Gold test (QFT) or Mantoux test (MT) at screening. Patients with a positive QFT or MT may participate in the study if further work up as per the opinion of the investigator (like Chest X-ray or CT scan of Chest or other locally acceptable method for diagnosing active tuberculosis) establishes that patient does not have active tuberculosis. Patients with latent tuberculosis should not be enrolled except when they are not planned to start prophylaxis for tuberculosis during the study period.
- History of hypersensitivity or idiosyncratic reaction to any investigational ROR-gamma inhibitors or any of the excipients of study drug
- History of alcohol or substance abuse that will affect compliance to study procedures/schedule as per Investigator opinion
- Any previous gastrointestinal surgery or recent (within 3 months) / current history of gastrointestinal disease, that in the opinion of investigator, could impact the absorption of the study drug
- Positive pregnancy test for women of child-bearing potential (WOCBP) at the screening or randomization visit
- Male patients who are sexually active with WOCBP, not willing to use reliable contraception methods as mentioned in section 8.14
- Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal contraceptive, IUD or any double combination of male or female condom, spermicidal gel, diaphragm, sponge, cervical cap). Please see section 8.14 for acceptable contraceptive practices
- Has received any investigational biologic agents within 3 months or 5 half-lives (whichever is longer) prior to the first administration of study drug
- Has received another new chemical entity/non-biologic investigational drug within 28 days or 5 half-lives of investigational drug (whichever is longer) prior to study day 1
- History of other auto-immune disorders (except psoriasis and psoriatic arthritis) where treatment with systemic immunosuppressants is required
- History of active infection and/or febrile illness within 7 days prior to Day 1. The infection adequately treated by antibiotics during the screening period as per investigator opinion will be allowed to undergo randomization, provided patient is stable for at least 7 days before randomization
- Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of person(s) with confirmed Covid-19 infection, at screening or Day 1
- History or presence of any major medical illness (e.g. renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active infection/infectious illness) or psychiatric disease, or clinically significant laboratory / ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
- History of any unstable cardiac (including Class III or IV congestive heart failure by New York Heart Association Criteria), respiratory, hepatic, renal or other systemic conditions within 3 months prior to first study drug administration
- Use of herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of study drug
- Patients who have received live attenuated vaccine in the 4 weeks prior to the first administration of study drug -
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2022
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04855721
Start Date
May 4 2021
End Date
December 10 2022
Last Update
December 13 2022
Active Locations (25)
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1
Johnson Dermatology
Fort Smith, Arkansas, United States, 72916
2
Northwest AR Clinical Trials Center
Rogers, Arkansas, United States, 72758
3
First OC Dermatology
Fountain Valley, California, United States, 92708
4
Dermatology Research Associates
Los Angeles, California, United States, 90045