Chronic Plaque-type PsoriasisPhase 2INDUS-2NCT04207801
A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis
A Phase 2 study testing AUR101 in people with Chronic Plaque-type Psoriasis, run by Aurigene Discovery Technologies Limited at 9 sites in India.
Trial summary
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of AUR101 (RORgamma inhibitor) in patients with moderate-to-severe psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Plaque-type Psoriasis
- What is being tested?
- AUR101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 9 sitesIndia
- Study dates
- 21 Jan 2020to 15 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. History of erythrodermic, guttate, or pustular psoriasis within last 12 months
- 2. Efficacy failure on any biologic (e.g. interleukin (IL) -17 antibodies or anti-TNF agents) for the treatment of psoriasis.
- 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 within 6 months prior to study day 1
- 6. Current treatment or history of treatment for psoriasis with other biological agents within 3 months prior to study day 1.
Show all 25Show fewer
- 7. Current treatment or history of treatment for psoriasis with non-biological systemic medications or phototherapy within 4 weeks prior to study day 1.
- 8. Treatment with medicated topical agents within 2 weeks prior to study day 1.
- 9. History or presence of any medical or psychiatric disease, or clinically significant laboratory at screening,
- 10. Evidence of organ dysfunction
- 11. Any major recent surgery history within 3 months prior to screening
- 12. Alcohol abuse or drug abuse
- 13. History of malignancy
- 14. Positive for HIV, Hepatitis B or Hepatitis C at screening.
- 15. Patient with known past history of systemic tuberculosis or currently suspected or known to have tuberculosis
- 16. Patient expected to be started on anti-tubercular therapy either for treatment or prophylaxis of tuberculosis.
- 17. Suspected tuberculosis infection as evident from a positive QuantiFERON TBGold test (QFT) at screening. Patients with a positive QFT test may participate in the study if further work up as per the opinion of the investigator .
- 18. History of hypersensitivity or idiosyncratic reaction to any investigational RORgamma inhibitors or any of the excipients of study drug
- 19. Past gastrointestinal surgery or recent (within 3 months) / current history of gastrointestinal disease.
- 20. Positive pregnancy test for women of child bearing potential (WOCBP) at the screening or randomization visit
- 21. Male patients with partners of childbearing potential not willing to use reliable contraception methods.
- 22. Pregnant or lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods
- 23. Has received another new chemical entity/investigational drug within 28 days or 5 half-lives of investigational drug prior to study day 1.
- 24. Use of herbal remedies, mega dose vitamins and minerals during the 2 weeks prior to the first administration of investigational product.
- 25. Patients who have received live or attenuated vaccine in the 4 weeks prior to study day 1.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
B.J Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016
Kempegowda Institute of Medical Sciences
Bangalore, Karnataka, 560004
Sapthagiri Hospital
Bangalore, Karnataka, 560090
Apex Hospitals Private Limited
Jaipur, Rajasthan, 302017
Life Line Diagnostic Centre Cum Nursing Home
Kolkata, West Bengal, 700016
Triveni Polyclinic
Nagpur, Maharashtra, 440008
Shree Hospital and Critical Care Centre
Nagpur, Maharashtra, 440009
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, Maharashtra, 440019
Sujata Birla Hospital & Medical Research Center
Nashik, Maharashtra, 422101
About this study
Official title: A Phase II, Multicenter, Double-blind, Double-dummy, Placebo Controlled, Randomized, Study to Evaluate the Efficacy and Safety of Two Doses of AUR101 in Patients With Moderate-to-Severe Psoriasis
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of AUR101 (RORgamma inhibitor) in patients with moderate-to-severe psoriasis.
Approximately 90 patients with chronic moderate-to-severe plaque psoriasis will be randomized to the 2 dose groups of AUR101 and one group of Placebo. The patients will receive the treatment for 12 weeks.
Read the detailed description
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of two doses of AUR101 in patients with moderate-to-severe psoriasis.
Approximately 90 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 the 2 dose groups of AUR101 and placebo in the ratio of 1:1:1.
The patients in each arm will receive AUR101 of 400 mg twice daily or AUR101 600 mg twice daily or matching placebo twice daily for 12 weeks in a double blind, double dummy fashion.
Every patient will receive 12 weeks of treatment. All the patients will be followed up for 14 ± 2 days of their last dose for safety assessment.
A subset of approximately 25 patients, who consent, will be asked to come for plasma PK assessment in week 4 of dosing.
Efficacy evaluation will be done by PASI, DLQI and BSA assessment. Safety assessment will be done by AEs and regular lab assessment.
- Conditions
- Chronic Plaque-type Psoriasis
- Being tested
- AUR101, Matching Placebo
- Keywords
- AUR101, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR101Drug
Also called No other names
Inhibitor of RORγ
Matching PlaceboDrug
Also called No other names
Drug-Placebo of AUR101 tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm-1 400 mg BID | Experimental | 400 mg AUR101 twice daily Receives: Drug: AUR101 |
| Arm-2 600 mg BID | Experimental | 600 mg AUR101 twice daily Receives: Drug: AUR101 |
| Arm-3 - Matching Placebo BID | Placebo comparator | Matching Placebo twice daily Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. Regulators commonly accept PASI 75 for measuring primary response of psoriasis in patients with Psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline
Measured: week 12
Secondary outcomes (7)
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline. These secondary measures are measured as Week 4 and Week 8 from the initiation of study drug therapy.
Measured: Week 4 and Week 8 from study drug initiation for these secondary outcomes measures
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 50 (i.e. 50% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 50 (i.e. 50% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate baseline and response of therapy in psoriasis. Like PASI 75, the PASI-50 is a binary outcome that indicates a 50% or greater improvement in PASI from baseline. PASI-50 is measured at Week 4, Week 8 and Week 12, as part of this secondary outcome measure.
Measured: Week 4, Week 8 and Week 12
Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1
The proportion of patients achieving Investigator Global Assessment (IGA) score of 0 or 1 (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)); The 5-point IGA has a more stringent definition for a score of 1 ("almost clear"); This secondary measure is measured at Week 4, Week 8 and Week 12. The sponsor has represented the proportion in % form by multiplying by 100. The sponsor has done that in CSR (Clinical Study Report) as well
Measured: Week 4, Week 8 and Week 12
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. Percent change from baseline in Psoriasis Area and Severity Index (PASI) score. The PASI is a widely used instrument in psoriasis trials that assesses and grades the severity of psoriatic lesions and the patient's response to treatment. It produces a numeric score ranging from 0 to 72. This outcome measures the percentage decrease in PASI from baseline at various pre-specified timepoints
Measured: week 4,8 and 12
Change From Baseline in Investigator Global Assessment (IGA) Scale
The 5-point IGA has a more stringent definition for a score of 1 ("almost clear") compared with 6-point IGA/Physician's Global Assessment (PGA) tools used in previous trials of other biologics in moderate-to-severe psoriasis. The IGA 0/1 rate is considered robust, demonstrating a strong association with PASI 90. The results for the 5-point IGA are expected to show the same association. This endpoint measures the percent change from baseline in Investigator Global Assessment (IGA) scale (Scores range from 0 (0 or 1 clear to mild) to 4 (severe)) at pre-specified time points.
Measured: week 4,8 and 12
Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved
BSA assessment measures the total area of the body affected by psoriasis. The body surface area (BSA) of involvement is an important indicator during the evaluation of psoriasis severity. In this secondary outcome measure, the change from baseline to week 4, 8 and 12 in percent Body Surface Area (BSA) involved is measured
Measured: week 4,8 and 12
Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a validated, 10-question, self-reported questionnaire to evaluate the patient's perception of the impact of psoriasis on their quality of life. The DLQI Scores range from 0 to 30, and higher scores indicate greater health-related quality-of-life impairment.
The DLQI questionnaire is divided into 6 commonly identified categories and is rated on a 4-point scale. This secondary outcome measures the change from baseline to week 4, 8 and 12 in Dermatology Life Quality Index (DLQI) score. The minimum value is 0 and maximum is 4
Measured: Week 4,8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start21 Jan 2020
- Primary completion20 Mar 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Plaque-type PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurigene Discovery Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shilendra Pandey, MSc, Study chair, Aurigene Discovery Techologies Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207801
- Sponsor's protocol ID
- AUR101-201
- Acronym
- INDUS-2
- Status last verified
- Jul 2023
- First submitted
- 19 Dec 2019
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Not yet planned to share
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Double-blind, Double-dummy, Placebo Controlled, Randomized, Study to Evaluate the Efficacy and Safety of Two Doses of AUR101 in Patients With Moderate-to-Severe Psoriasis
- ClinicalTrials.gov ID
- NCT04207801
- Acronym / sponsor ID
- INDUS-2 / AUR101-201
- Conditions
- Chronic Plaque-type Psoriasis
- Keywords
- AUR101, Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of AUR101 (RORgamma inhibitor) in patients with moderate-to-severe psoriasis.
Approximately 90 patients with chronic moderate-to-severe plaque psoriasis will be randomized to the 2 dose groups of AUR101 and one group of Placebo. The patients will receive the treatment for 12 weeks.
Detailed description
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of two doses of AUR101 in patients with moderate-to-severe psoriasis.
Approximately 90 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 the 2 dose groups of AUR101 and placebo in the ratio of 1:1:1.
The patients in each arm will receive AUR101 of 400 mg twice daily or AUR101 600 mg twice daily or matching placebo twice daily for 12 weeks in a double blind, double dummy fashion.
Every patient will receive 12 weeks of treatment. All the patients will be followed up for 14 ± 2 days of their last dose for safety assessment.
A subset of approximately 25 patients, who consent, will be asked to come for plasma PK assessment in week 4 of dosing.
Efficacy evaluation will be done by PASI, DLQI and BSA assessment. Safety assessment will be done by AEs and regular lab assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm-1 400 mg BID | Experimental | Drug: AUR101400 mg AUR101 twice daily |
| Arm-2 600 mg BID | Experimental | Drug: AUR101600 mg AUR101 twice daily |
| Arm-3 - Matching Placebo BID | Placebo comparator | Drug: Matching PlaceboMatching Placebo twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 1. History of erythrodermic, guttate, or pustular psoriasis within last 12 months
- 2. Efficacy failure on any biologic (e.g. interleukin (IL) -17 antibodies or anti-TNF agents) for the treatment of psoriasis.
- 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 within 6 months prior to study day 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUR101Also: No other namesInhibitor of RORγ | Drug | Arm-1 400 mg BID, Arm-2 600 mg BID |
| Matching PlaceboAlso: No other namesDrug-Placebo of AUR101 tablet | Drug | Arm-3 - Matching Placebo BID |
Primary outcome
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Time frame: week 12
Proportion of patients achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% reduction from baseline PASI score). (Scores range from 0 (minimum) to 30 (maximum)); The PASI is a scoring system to evaluate the baseline and response of therapy in psoriasis. Regulators commonly accept PASI 75 for measuring primary response of psoriasis in patients with Psoriasis. PASI 75 is a binary outcome that indicates a 75% or greater improvement in PASI from baseline
7 secondary outcomes
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Time frame: Week 4 and Week 8 from study drug initiation for these secondary outcomes measures
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 50 (i.e. 50% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))
Time frame: Week 4, Week 8 and Week 12
Proportion of Patients Achieving Investigator Global Assessment (IGA) Score of 0 or 1
Time frame: Week 4, Week 8 and Week 12
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score.
Time frame: week 4,8 and 12
Change From Baseline in Investigator Global Assessment (IGA) Scale
Time frame: week 4,8 and 12
Change From Baseline to Week 4, 8 and 12 in Percent Body Surface Area (BSA) Involved
Time frame: week 4,8 and 12
Change From Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Week 4,8 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not yet planned to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shilendra Pandey, MSc study chair
Aurigene Discovery Techologies Limited
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUR101 in people with Chronic Plaque-type Psoriasis, run by Aurigene Discovery Technologies Limited at 9 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum)) (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.