AUR101 for Psoriasis Vulgaris (Plaque Psoriasis)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
FXM Clinical Research Miami LLC, Miami, FL
Psoriasis Vulgaris (Plaque Psoriasis)+1 More
AUR101 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat psoriasis.

See full description

Eligible Conditions

  • Psoriasis Vulgaris (Plaque Psoriasis)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Psoriasis Vulgaris (Plaque Psoriasis)

Study Objectives

This trial is evaluating whether AUR101 will improve 1 primary outcome, 18 secondary outcomes, and 11 other outcomes in patients with Psoriasis Vulgaris (Plaque Psoriasis). Measurement will happen over the course of Week 4.

Week 14
Changes in Blood Pressure
Changes in CBC (Complete Blood Count)
Changes in Liver Function Tests
Changes in Pulse Rate
Changes in Respiratory Rate
Changes in Temperature
Changes in weight
Nature and incidence of Treatment Emergent Adverse Events (TEAEs)
Week 12
Percent change from baseline in PASI score at week 12
Percent change from baseline to week 12 in percent BSA involved
Proportion of patients achieving DLQI score of 0 or 1 at week 12
Proportion of patients achieving IGA 0 or 1 at week 12
Proportion of patients achieving PASI 50, PASI 90 and PASI 100 response at 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 12.
Week 14
Changes in PR interval in ECG (Electro Cardio Gram)
Changes in QRS interval in ECG (Electro Cardio Gram)
Changes in QTc interval in ECG (Electro Cardio Gram)
Week 16
Percent change from baseline in PASI score at week 16
Proportion of patients achieving DLQI 0 or 1 score
Proportion of patients achieving IGA 0 or 1 response
Proportion of patients achieving PASI 100 response
Proportion of patients achieving PASI 50 response
Proportion of patients achieving PASI 75 response
Proportion of patients achieving PASI 90 response
Week 4
Metabolite of AUR101 identification from plasma collected at week 4
Metabolite of AUR101 identification from urine collected at week 4
Metabolite of AUR101 quantification from plasma collected at week 4
Metabolite of AUR101 quantification from urine collected at week 4
Plasma Pharmacokinetic parameters at week 4
Week 8
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Psoriasis Vulgaris (Plaque Psoriasis)

Trial Design

4 Treatment Groups

AUR101 400 mg PO BID
1 of 4
AUR101 200 mg PO BID
1 of 4
AUR101 400 mg PO QD
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 128 total participants across 4 different treatment groups

This trial involves 4 different treatments. AUR101 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

AUR101 400 mg PO BID
Drug
Patients will receive AUR101 / placebo in double blind, double dummy manner
AUR101 200 mg PO BID
Drug
Patients will receive AUR101 / placebo in double blind, double dummy manner
AUR101 400 mg PO QD
Drug
Patients will receive AUR101 / placebo in double blind, double dummy manner
Placebo
Drug
Patients will receive AUR101 / placebo in double blind, double dummy manner
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AUR101
2020
Completed Phase 2
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 through follow up visit at week 14
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from day 1 through follow up visit at week 14 for reporting.

Closest Location

FXM Clinical Research Miami LLC - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What is psoriasis?

"According to latest research, psoriasis causes a group of very common skin ailments. The diseases most people have been diagnosed with this disease by are acne and psoriasis (common on the faces, arms, ears, back, buttocks and limbs) The symptoms of psoriasis often come and go and the disease tends to be a lifelong condition." - Anonymous Online Contributor

Unverified Answer

What are the signs of psoriasis?

"The symptoms of psoriasis are often similar to those of other dermatologic conditions and thus can be difficult to detect. Some signs of psoriasis include itching, skin changes such as redness and scaling, or swelling (especially in the joints) of the extremities. Other symptoms may include nail change, nail loss, thickened hair growth, discolouration of nail, acne vulgaris, and seborrhea (the abnormal shedding of oily skin). If psoriasis spreads to the scalp it may cause a very painful sensation and may make breathing difficult due to the skin pulling on the cheeks." - Anonymous Online Contributor

Unverified Answer

What causes psoriasis?

"There is evidence that psoriasis develops as a result of environmental and genetic factors; psoriasis may occur more often with advancing age or in children with atopy. It is not determined whether psoriasis results when a person inherits a defect in psoriatic erythematous lesions." - Anonymous Online Contributor

Unverified Answer

How many people get psoriasis a year in the United States?

"Recent findings of the current study suggest that, in the United States, approximately half of psoriatic patients present with psoriasis by the age of 40, and the prevalence is higher among men. The findings from this first population-based study suggest that psoriasis has a prevalence of approximately 5% and is more common among women." - Anonymous Online Contributor

Unverified Answer

Can psoriasis be cured?

"The present clinical evidence suggests that the treatment of psoriasis is not an easy problem, and it is important to understand psoriasis and its treatment, to formulate effective treatment plans for patients with psoriasis, and to develop new medications for the treatment of psoriasis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for psoriasis?

"Dapsone, methotrexate, or ustekinumab are the first-line treatments for psoriasis. Other antipsoritic medications such as phototherapy or psoralen plus ultraviolet A treatment, are used for severe disease. Combination treatment with psoralen plus ultraviolet A and photodynamic therapy is often used for severe cases. It is also used to prevent exacerbation in severe cases of psoriasis with medication or phototherapy." - Anonymous Online Contributor

Unverified Answer

How serious can psoriasis be?

"As the condition worsens, psoriasis could be a serious health challenge to patients. It is important to recognize psoriasis severity, and to find appropriate treatment and control it at the root. Treating psoriasis effectively is important during both the acute and the later phase of its progress." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of psoriasis?

"The cause of psoriasis still remains unclear and is still being investigated. A combination of genetic and environmental factors, such as a viral infection, have been suggested to play a substantial role in psoriasis. It appears that these factors act in synergy to cause an autoimmune response in the skin and joints. However, the underlying etiological factors are still being explored. The use of dietary interventions and dietary supplements may be a promising approach in the treatment of psoriasis. The underlying etiological factors would also probably have significant impact on relapse rates, disease duration, disease severity, medication requirements and treatment outcomes." - Anonymous Online Contributor

Unverified Answer

Is aur101 typically used in combination with any other treatments?

"Aur101 is an effective medication in its own right when compared to placebo for the treatment of PHA. The combination of Aur101 with tacrolimus ointment is a reasonable option for patients with psoriatic skin lesions who complain about the pruritus of an existing treatment. However, a head to head comparison between these 3 treatments is not yet available. It may be worthwhile to consider the combination of Aur101 with tacrolimus ointment when both PHA and psoriasis are present." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of aur101?

"Aur101 is an orphan drug in India. There is a lack of reported data comparing drug safety of aur101 to other drugs. Thus, long term clinical trials as well as trials in larger populations are required in order to establish safety profile." - Anonymous Online Contributor

Unverified Answer

Does psoriasis run in families?

"Psoriasis is a genetically heterogeneous condition with a complex mode of inheritance. The frequency of psoriasis in patients with psoroainuria has not been definitively established. In this report, we found that one-third of patients with familial psoriasis and psoroid lesions had evidence of psoriasis in their relatives in whom no family history of psoriasis was found. This is consistent with a new hypothesis, the familial aggregation of psoriasis. Thus, psoriasis should be considered a new familial or autoimmune disease." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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