Imsidolimab for Hidradenitis Suppurativa

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Site 30-103, Ossy, Poland
Hidradenitis Suppurativa+1 More
Imsidolimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa

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Eligible Conditions

  • Hidradenitis Suppurativa

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hidradenitis Suppurativa

Study Objectives

This trial is evaluating whether Imsidolimab will improve 1 primary outcome in patients with Hidradenitis Suppurativa. Measurement will happen over the course of Change in baseline in abscess and inflammatory nodule (AN) count at Week 16.

Week 16
To evaluate the efficacy of imsidolimab in subjects with HS

Trial Safety

Safety Progress

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

Other trials for Hidradenitis Suppurativa

Side Effects for

Imsidolimab
Oropharyngeal pain
25%
Hypokalemia
13%
Hypertension
13%
White blood cell count increased
13%
C-reactive protein increased
13%
Myxomatous mitral valve degeneration
13%
Peripheral swelling
13%
Lymphadenopathy
13%
COVID-19
13%
Vaginal haemorrhage
13%
Humerus fracture
13%
Presyncope
13%
Blood glucose increased
13%
Psoriasis
13%
Blood folate decreased
13%
Anaemia
13%
Mitral valve prolapse
13%
Acute kidney injury
13%
Skin haemorrhage
13%
Swelling face
13%
Nosocomial infection
13%
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03619902) in the Imsidolimab ARM group. Side effects include: Oropharyngeal pain with 25%, Hypokalemia with 13%, Hypertension with 13%, White blood cell count increased with 13%, C-reactive protein increased with 13%.

Trial Design

3 Treatment Groups

ANB019 Biological Humanized Monoclonal Antibody High Dose
1 of 3
ANB019 Biological Humanized Monoclonal Antibody Low Dose
1 of 3
Placebo Solution
1 of 3
Experimental Treatment
Non-Treatment Group

This trial requires 120 total participants across 3 different treatment groups

This trial involves 3 different treatments. Imsidolimab is the primary treatment being studied. Participants will be divided into 2 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.

ANB019 Biological Humanized Monoclonal Antibody High Dose
Biological
ANB019 Biological Humanized Monoclonal Antibody Low Dose
Biological
Placebo Solution
Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imsidolimab
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in baseline in abscess and inflammatory nodule (an) count at week 16
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change in baseline in abscess and inflammatory nodule (an) count at week 16 for reporting.

Closest Location

Site 11-105 - Québec, Canada

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:
5 cm in length If the fistula is ≤ 20.5 cm in length, it is best to drain it. show original
The patient must have had stable HS for at least six weeks prior to the Day 1 visit. show original
The person has had a confirmed diagnosis of HS that has lasted for at least six months before the first day of the study. show original
HS lesions can be found in at least two different places on the body. show original
Any adult aged 18 to 75 who is willing and able to provide informed consent is eligible to participate in the study. show original
Total AN count ≥ 5.

Patient Q&A Section

What is the average age someone gets hidradenitis?

"Hormonal changes, particularly those that affect skin, occur at a more gradual age in women than in men, who more frequently encounter the disorder and develop a full-blown histological pattern." - Anonymous Online Contributor

Unverified Answer

Can hidradenitis be cured?

"The data from this study suggest that hidradenitis can be completely reversed with a course of antibiotic therapy over a period of 7 months with complete resolution of the clinical symptomatology." - Anonymous Online Contributor

Unverified Answer

What causes hidradenitis?

"Skin lesions often resolve upon discontinuation of the offending agent in patients who have had hidradenitis fugax or episodic hidradenitis for less than 1 year. However, this typically happens within less than a month. A more rapid improvement in the lesions has been reported with topical corticosteroids or more intensive treatment. In these patients, patients may be diagnosed with episodic hidradenitis fugax. This rapid improvement indicates that this diagnosis is not appropriate and should be changed to episodic hidradenitis, which requires protracted treatment and results in much slower resolution over days to weeks. Most patients with hidradenitis, regardless of diagnosis, tend to have a protracted course of the disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of hidradenitis?

"Most sufferers of hidradenitis and hidradenitis microunica will have a history of trauma to the area in the form of sharp stones entering through the anus or nose. The initial symptoms might include a sore feeling, itching, and/or irritation. As the lump develops, the symptoms will progressively worsen and the lump will begin to grow much larger - often reaching the age of 7 in children. The lump can also develop into a thick papule, but may not be painful at any stage of the growth. In severe cases the lump will grow so large that it impedes the flow of stool or blood (anemic colic)." - Anonymous Online Contributor

Unverified Answer

What is hidradenitis?

"This syndrome is a rare noninflammatory thyroid hormone excess due to deposition atypical colloid nodules. Patients with hidradenitis complain of the presence of nodules in both nodular and non-nodular glands of the thyroid. We describe two patients, one from Tunisia and one from Egypt, who were diagnosed with hidradenitis. We also provide a comprehensive review of the literature. Clinical features were unremarkable; physical signs and laboratory investigations were usually normal. Ultrasonography can be used for confirming the diagnosis in patients with nonpalpable nodules but its lack of specificity can lead to unnecessary thyroidectomy and consequent surgical complications." - Anonymous Online Contributor

Unverified Answer

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

"About 75,000 cases of hidradenitis are diagnosed each year in the United States, making it the third leading cause of chronic inflammatory skin lesions in this country." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hidradenitis?

"Since most drugs are used in several different treatment schedules, multiple medications may be needed to reduce the severity of inflammatory lesions and pain and to decrease progression to fibrosis. However, treatments appear effective in most patients with hidradenitis, and only half of patients in this series required surgical intervention. In a recent study, findings will help guide patients and providers through challenging diagnostic and treatment decisions." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hidradenitis?

"Findings from a recent study suggest that the primary cause of hidradenitis is not unilateral obstruction, but rather multifactorial defects in both upper airway physiology and lower airway clearance, specifically impaired mucociliary function." - Anonymous Online Contributor

Unverified Answer

How does imsidolimab work?

"Immunosuppressive T1D is characterized by a high prevalence of autoimmune thyroiditis and subclinical hypothyroidism and requires a multidisciplinary approach to the diagnosis and treatment of autoimmune thyroid disease." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hidradenitis?

"In a recent study, findings suggest that C1-inhibitor inhibitor treatment might be used as a treatment for hidradenitis patients. In a recent study, findings provide the evidence for that treatment. However, clinical studies with a longer randomized controlled and larger patient number should be done." - Anonymous Online Contributor

Unverified Answer

Does hidradenitis run in families?

"A significant proportion of familial hidradenitis patients have signs of ARDS. No genetic contribution to the phenotype was determined. Therefore, other factors must be involved in the genesis of familial hidradenitis." - Anonymous Online Contributor

Unverified Answer

What does imsidolimab usually treat?

"The vast majority of the study's patients have been in remission since immunization began, with durable response rates comparable to those reported in the clinical trials of other biologics. Treatment with Imsidolimab led to sustained improvement in most patients with IBD and/or AA associated with IFX use. Patient satisfaction with the treatment was highly favorable." - 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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