CLINICAL TRIAL

RIST4721 for Hidradenitis

Waitlist Available · 18+ · All Sexes · Coral Gables, FL

A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

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About the trial for Hidradenitis

Eligible Conditions
Hidradenitis · Hidradenitis Suppurativa

Treatment Groups

This trial involves 2 different treatments. RIST4721 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
RIST4721
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RIST4721
2019
Completed Phase 2
~70

Side Effect Profile for RIST4721 300 mg

RIST4721 300 mg
Show all side effects
33%
Diarrhoea
20%
Urine odour abnormal
13%
Folliculitis
13%
Neutropenia
13%
Procedural pain
13%
Abnormal faeces
13%
Nausea
13%
Musculoskeletal stiffness
7%
Concussion
7%
Anxiety
7%
Leukopenia
7%
Increased appetite
7%
Post procedural cellulitis
7%
Cough
7%
Abdominal pain
7%
Blood triglycerides increased
7%
Fatigue
7%
Bacterial test
7%
Decreased appetite
7%
Blood glucose increased
7%
Hepatic enzyme increased
7%
Osteoarthritis
7%
Pain in extremity
7%
Skin fissures
7%
Headache
0%
Dizziness
0%
Micturition disorder
0%
Myalgia
0%
Vaginal haemorrhage
0%
Back pain
0%
Nasopharyngitis
0%
Ligament sprain
Diarrhoea
33%
Urine odour abnormal
20%
Folliculitis
13%
Neutropenia
13%
Procedural pain
13%
Abnormal faeces
13%
Nausea
13%
Musculoskeletal stiffness
13%
Concussion
7%
Anxiety
7%
Leukopenia
7%
Increased appetite
7%
Post procedural cellulitis
7%
Cough
7%
Abdominal pain
7%
Blood triglycerides increased
7%
Fatigue
7%
Bacterial test
7%
Decreased appetite
7%
Blood glucose increased
7%
Hepatic enzyme increased
7%
Osteoarthritis
7%
Pain in extremity
7%
Skin fissures
7%
Headache
7%
Dizziness
0%
Micturition disorder
0%
Myalgia
0%
Vaginal haemorrhage
0%
Back pain
0%
Nasopharyngitis
0%
Ligament sprain
0%
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03988335) in the RIST4721 300 mg ARM group. Side effects include: Diarrhoea with 33%, Urine odour abnormal with 20%, Folliculitis with 13%, Neutropenia with 13%, Procedural pain with 13%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have had HS for at least 1 year. show original
HS lesions must be present in at least 2 distinct anatomic areas
A total AN count (sum of abscesses and inflammatory nodules) > 6 across all anatomical sites at both the screening and baseline visits
Willing to use contraception for the duration of the study
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to Week 12
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to Week 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to Week 12.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether RIST4721 will improve 1 primary outcome and 1 secondary outcome in patients with Hidradenitis. Measurement will happen over the course of Baseline to Week 12.

Incidence of TEAEs and SAEs
BASELINE TO WEEK 12
BASELINE TO WEEK 12
Proportion of subjects achieving HiSCR50 at Week 12
BASELINE TO WEEK 12
BASELINE TO WEEK 12

Patient Q & A Section

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

What causes hidradenitis?

Hidradenitis can occur via a number of factors, though it may be most often caused by a viral infection of the salivary gland. Hidradenitis may involve the entire gland or a part of one lobe. Patients should be referred for diagnostic tests if they complain of itching or a discharge coming from the duct opening.

Anonymous Patient Answer

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

The percentage of patients with hidradenitis over the last decade has been increasing. The percentage appears to reach a peak between 30 and 60 years of age.

Anonymous Patient Answer

What is hidradenitis?

(1) The cause of hidradenitis is unknown; (2) A wide variety of dermatological and surgical conditions may cause hidradenitis. (3) The name hidradenitis refers to both the condition being described and its pathogenesis. (4) Diversion may be the best therapeutic approach.

Anonymous Patient Answer

What are common treatments for hidradenitis?

There are various treatment options for hidradenitis, including medication. Topical oil and ice can be useful for pain relief and discomfort, while thermal therapy can reduce the redness. Systemic (immunosuppressive, surgical) and topical (topical oil and ice) treatment options are frequently used. Topical steroid, immunosuppressive, surgical and radiation therapies are used at special clinics where these conditions are more common.

Anonymous Patient Answer

What are the signs of hidradenitis?

It is a skin problem that may produce painful or itching skin nodules.\n\nThe aim of this test is to identify whether an oil has a pore, which will allow it to be absorbed by a barrier into the dermis.\n\nThis is done by using a pore cream, which will be applied to the skin. A drop of pore cream is then placed on to some cotton wool and rubbed over the skin.\n\nA visual sign of the presence of pimples is a visible bump. A bump or pimple will also be present on the upper lip or corner of the nose.

Anonymous Patient Answer

Can hidradenitis be cured?

Results from a recent clinical trial show high cure rate of hidradenitis (70%). There was no recurrence after 4 years follow-up. In some cases, it was possible to cure repeated attacks by the excimer laser, particularly in patients with severe symptoms.

Anonymous Patient Answer

Have there been other clinical trials involving rist4721?

As of 2018, there have been four clinical trials investigating the use of rist4721. The first clinical trial was conducted in the United Kingdom in 2015, and the four subsequent trials had all been completed (2016 to 2019). In a recent study, findings of these trials are awaited. \nPublished as of February 2020.\n\n- ClinicalTrials.

Anonymous Patient Answer

What are the latest developments in rist4721 for therapeutic use?

Rist4721 has been approved by Chinese State Food and Drug Administration (SFDA) and is being studied for clinical applications in the treatment of Hidradenitis suppurativa and inflammatory acne in the United States. It has been shown effective in studies conducted in China and in France. A Phase 2 clinical study conducted in the US is expected to conclude by December 2013. A Phase 3 clinical study was started in late 2014 and the study is expected to be completed in the spring of 2016. Currently, rist 4721 is on marketing authorization in Europe and the EU will monitor its progress during the next 2 years, ensuring it is the only medicine on the market. Rist 4721 has been approved for therapeutic use in China and Russia.

Anonymous Patient Answer

What is the primary cause of hidradenitis?

The primary cause of hidradenitis is a virus. The viral process, as well as genetic factors, are more important in the development of hidradenitis than hormonal factors. The primary viruses causing hidradenitis are a type of adenovirus called adenovirus 7 and the human papilloma virus (HPV). Other viruses affecting the genitals as well as some hormonal events may also contribute to hidradenitis. A variety of techniques can be used to aid diagnosis, including a skin biopsy, which involves taking a sample from a bump or skin lesion to rule out molluscum contagiosum or condyloma acuminatum.

Anonymous Patient Answer

Have there been any new discoveries for treating hidradenitis?

Currently, only the treatment of the underlying cause is practiced in the management of this disorder. This article highlights several new treatments, including laser therapy, and a review.

Anonymous Patient Answer

What are the common side effects of rist4721?

Most common side effects observed were mild; transient irritation of skin, pain or swelling at injection site, headache, dysgeusia (dysrhythmia), and rash or erythema at injection site. Patients with mild side effects in a clinical trial may have a greater chance of having a positive clinical response.

Anonymous Patient Answer

Does hidradenitis run in families?

We observed a high frequency of HIDA and HID-HD among the family members. Data from a recent study are supporting the possible role of an environmental factor in the aetiology of HIDA.

Anonymous Patient Answer
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