Plaque PsoriasisPhase 2INDUS-3NCT04855721
A Dose-Ranging Phase II Study of AUR101 in Psoriasis (INDUS-3)
A Phase 2 study testing AUR101 in people with Plaque Psoriasis, run by Aurigene Discovery Technologies Limited at 25 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque 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
- 141 participants
- Where
- 25 sitesUnited States
- Study dates
- 4 May 2021to 10 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 29Show fewer
- 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 -
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Great Lakes Research Group, Inc
Bay City, Michigan, 48706
Moore Clinical Research, Inc.
Brandon, Florida, 33511
Skin Research Institute
Coral Gables, Florida, 33146
Dermatology Treatment & Research Center
Dallas, Texas, 75230
Accel Research Sites - Deland CRU
DeLand, Florida, 32720
FXM Clinical Research Fort Lauderdale
Fort Lauderdale, Florida, 33308
Johnson Dermatology
Fort Smith, Arkansas, 72916
First OC Dermatology
Fountain Valley, California, 92708
Direct Helpers Research Center
Hialeah, Florida, 33012
Abys New Generation Research Inc.
Hialeah, Florida, 33016
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Dermatology Research Associates
Los Angeles, California, 90045
FXM Clinical Research Miami LLC
Miami, Florida, 33175
Floridian Reserach
Miami, Florida, 33179
FXM Clinical Research Miramar LLC
Miramar, Florida, 33027
The Dermatology Specialists
New York, New York, 10012
Sadick Research Group
New York, New York, 10075
Paddington Testing Co, Inc
Philadelphia, Pennsylvania, 19103
Northwest AR Clinical Trials Center
Rogers, Arkansas, 72758
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
University Clinical Trials, Inc.
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Unison Clinical Trials
Sherman Oaks, California, 91403
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172
Center for Clinical Studies Ltd., LLP.
Webster, Texas, 77598
About this study
Official title: 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)
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)
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- AUR101, Placebo
- Keywords
- psoriasis, AUR101, ROR, RORgamma, RORgamma inverse agonist, RORgamma inhibitor
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUR101Drug
Oral ROR-gamma inverse agonist
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AUR101 400 mg PO BID | Experimental | Patients will receive AUR101 / placebo in double blind, double dummy manner Receives: Drug: AUR101 |
| AUR101 200 mg PO BID | Experimental | Patients will receive AUR101 / placebo in double blind, double dummy manner Receives: Drug: AUR101 |
| AUR101 400 mg PO QD | Experimental | Patients will receive AUR101 / placebo in double blind, double dummy manner Receives: Drug: AUR101 |
| Placebo | Placebo comparator | Patients will receive AUR101 / placebo in double blind, double dummy manner Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
PASI-75; A higher proportion of patients reaching PASI-75 means betterment in higher proportion of patients
Measured: Week 12
Secondary outcomes (19)
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
PASI-75; A higher proportion of patients reaching PASI-75 means betterment in higher proportion of patients
Measured: Week 4 and Week 8
Proportion of patients achieving PASI 50, PASI 90 and PASI 100 response at week 12.
PASI-50, PASI-90, PASI-100; A higher proportion of patients reaching PASI-50, PASI-90 or PASI-100 means betterment in higher proportion of patients
Measured: Week 12
Proportion of patients achieving IGA 0 or 1 at week 12
IGA (Investigator's Global Assessment); Lower scores are better
Measured: Week 12
Percent change from baseline in PASI score at week 12
Percent Change in PASI from baseline
Measured: Week 12
Percent change from baseline to week 12 in percent BSA involved
Percent Change in BSA (body surface area) from baseline
Measured: Week 12
Proportion of patients achieving DLQI score of 0 or 1 at week 12
DLQI (Dermatology Life Quality Index) Score; Lower scores are better; Maximum score of 30 and minimum of 0
Measured: Week 12
Plasma Pharmacokinetic parameters at week 4
Cmax (maximum Plasma concentration)
Measured: Week 4
Plasma Pharmacokinetic parameters at week 4
AUC0-8 (Area Under The Curve for 8 hours) after morning drug administration
Measured: Week 4
Nature and incidence of Treatment Emergent Adverse Events (TEAEs)
All Adverse Events which occur from the administration of study drug
Measured: From Day 1 through Follow Up Visit at Week 14
Changes in Blood Pressure
Both systolic and diastolic Blood Pressure changes during trial will be measured
Measured: From Day 1 through Follow Up Visit at Week 14
Changes in Pulse Rate
Pulse Rate changes during trial
Measured: From Day 1 through Follow Up Visit at Week 14
Changes in Temperature
Body temperature changes during trial
Measured: From Day 1 through Follow Up Visit at Week 14
Changes in Respiratory Rate
Respiratory Rate changes during trial
Measured: From Day 1 through Follow Up Visit at Week 14
Changes in PR interval in ECG (Electro Cardio Gram)
Changes in PR Interval
Measured: Week 14 (Follow Up Visit)
Changes in QRS interval in ECG (Electro Cardio Gram)
Changes in QRS Interval
Measured: Week 14 (Follow Up Visit)
Changes in QTc interval in ECG (Electro Cardio Gram)
Changes in QTc Interval
Measured: Week 14 (Follow Up Visit)
Changes in CBC (Complete Blood Count)
Complete Blood Count (CBC)
Measured: From Day 1 through Follow Up Visit at Week 14
Changes in Liver Function Tests
Liver Function Tests (AST, ALT, Total Bilirubin)
Measured: From Day 1 through Follow Up Visit at Week 14
Changes in weight
Weight (in pounds) will be measured at all visits and change in weight (in pounds) will be presented
Measured: From Day 1 through Follow Up Visit at Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start4 May 2021
- Primary completion30 Nov 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- Model description
- There are 4 groups in the study; 1 with placebo and 3 with different AUR101 dosing regimens
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurigene Discovery Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Divyesh Mandavia, MD, Study director, Aurigene Discovery Technologies Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855721
- Sponsor's protocol ID
- AUR101-202
- Acronym
- INDUS-3
- Status last verified
- Dec 2022
- First submitted
- 15 Apr 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only IPD (such as SUSAR) required by FDA and IRBs will be shared with other researchers. Aggregate data will be shared with all researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. 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 AUR101 in Patients With Moderate-to-Severe Psoriasis (INDUS-3)
- ClinicalTrials.gov ID
- NCT04855721
- Acronym / sponsor ID
- INDUS-3 / AUR101-202
- Conditions
- Plaque Psoriasis
- Keywords
- psoriasis, AUR101, ROR, RORgamma, RORgamma inverse agonist, RORgamma inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Aurigene Discovery Technologies LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- There are 4 groups in the study; 1 with placebo and 3 with different AUR101 dosing regimens
| Arm | Type | Receives |
|---|---|---|
| AUR101 400 mg PO BID | Experimental | Drug: AUR101Patients will receive AUR101 / placebo in double blind, double dummy manner |
| AUR101 200 mg PO BID | Experimental | Drug: AUR101Patients will receive AUR101 / placebo in double blind, double dummy manner |
| AUR101 400 mg PO QD | Experimental | Drug: AUR101Patients will receive AUR101 / placebo in double blind, double dummy manner |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive AUR101 / placebo in double blind, double dummy manner |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (29 listed)
- 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
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 |
|---|---|---|
| AUR101Oral ROR-gamma inverse agonist | Drug | AUR101 200 mg PO BID, AUR101 400 mg PO BID, AUR101 400 mg PO QD |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
19 secondary 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 4 and 8
Time frame: Week 4 and Week 8
Proportion of patients achieving PASI 50, PASI 90 and PASI 100 response at week 12.
Time frame: Week 12
Proportion of patients achieving IGA 0 or 1 at week 12
Time frame: Week 12
Percent change from baseline in PASI score at week 12
Time frame: Week 12
Percent change from baseline to week 12 in percent BSA involved
Time frame: Week 12
Proportion of patients achieving DLQI score of 0 or 1 at week 12
Time frame: Week 12
Plasma Pharmacokinetic parameters at week 4
Time frame: Week 4
Plasma Pharmacokinetic parameters at week 4
Time frame: Week 4
Nature and incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: From Day 1 through Follow Up Visit at Week 14
Changes in Blood Pressure
Time frame: From Day 1 through Follow Up Visit at Week 14
Changes in Pulse Rate
Time frame: From Day 1 through Follow Up Visit at Week 14
Changes in Temperature
Time frame: From Day 1 through Follow Up Visit at Week 14
Changes in Respiratory Rate
Time frame: From Day 1 through Follow Up Visit at Week 14
Changes in PR interval in ECG (Electro Cardio Gram)
Time frame: Week 14 (Follow Up Visit)
Changes in QRS interval in ECG (Electro Cardio Gram)
Time frame: Week 14 (Follow Up Visit)
Changes in QTc interval in ECG (Electro Cardio Gram)
Time frame: Week 14 (Follow Up Visit)
Changes in CBC (Complete Blood Count)
Time frame: From Day 1 through Follow Up Visit at Week 14
Changes in Liver Function Tests
Time frame: From Day 1 through Follow Up Visit at Week 14
Changes in weight
Time frame: From Day 1 through Follow Up Visit at Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No. Only IPD (such as SUSAR) required by FDA and IRBs will be shared with other researchers. Aggregate data will be shared with all researchers.
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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.
Divyesh Mandavia, MD study director
Aurigene Discovery Technologies Limited
25 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 Plaque Psoriasis, run by Aurigene Discovery Technologies Limited at 25 sites in United States.
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 6 inclusion and 29 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 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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). 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 13 Dec 2022.