A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)

Completed · Phase 2 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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)

Key facts

Study ID

NCT04855721

Run by

Aurigene Discovery Technologies Limited

People needed

141

Starts

2021-05-04

Expected to finish

2022-12-10

Last updated by the study team

2022-12-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johnson Dermatology — Fort Smith, Arkansas, United States
• Northwest AR Clinical Trials Center — Rogers, Arkansas, United States
• First OC Dermatology — Fountain Valley, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• University Clinical Trials, Inc. — San Diego, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• Unison Clinical Trials — Sherman Oaks, California, United States
• Moore Clinical Research, Inc. — Brandon, Florida, United States
• Skin Research Institute — Coral Gables, Florida, United States
• Accel Research Sites - Deland CRU — DeLand, Florida, United States
• FXM Clinical Research Fort Lauderdale — Fort Lauderdale, Florida, United States
• Direct Helpers Research Center — Hialeah, Florida, United States
• Abys New Generation Research Inc. — Hialeah, Florida, United States
• FXM Clinical Research Miami LLC — Miami, Florida, United States
• Floridian Reserach — Miami, Florida, United States
• FXM Clinical Research Miramar LLC — Miramar, Florida, United States
• Lenus Research & Medical Group, LLC — Sweetwater, Florida, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Great Lakes Research Group, Inc — Bay City, Michigan, United States
• Medisearch Clinical Trials — Saint Joseph, Missouri, United States
• The Dermatology Specialists — New York, New York, United States
• Sadick Research Group — New York, New York, United States
• Paddington Testing Co, Inc — Philadelphia, Pennsylvania, United States
• Dermatology Treatment & Research Center — Dallas, Texas, United States
• Center for Clinical Studies Ltd., LLP. — Webster, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.