Imsidolimab for Acne

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Site 10-105, Murfreesboro, TN
Acne
Imsidolimab - Drug
Eligibility
< 65
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 Acne Vulgaris

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Acne

Study Objectives

This trial is evaluating whether Imsidolimab will improve 1 primary outcome in patients with Acne. Measurement will happen over the course of Change from baseline in facial inflammatory lesion count at week 12.

Week 12
To determine the effect of Imsidolimab compared with placebo change from baseline in facial inflammatory lesion count at week 12.

Trial Safety

Safety Progress

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

Other trials for Acne

Side Effects for

Imsidolimab
Oropharyngeal pain
25%
COVID-19
13%
Vaginal haemorrhage
13%
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%
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%, COVID-19 with 13%, Vaginal haemorrhage with 13%, Hypokalemia with 13%, Hypertension with 13%.

Trial Design

3 Treatment Groups

Low Dose Arm: Imsidolimab Biological humanized antibody
1 of 3
High Dose Arm: Imsidolimab Biological humanized antibody
1 of 3
Placebo
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.

Low Dose Arm: Imsidolimab Biological humanized antibody
Drug
High Dose Arm: Imsidolimab Biological humanized antibody
Drug
Placebo
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 from baseline in facial inflammatory lesion count at week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline in facial inflammatory lesion count at week 12 for reporting.

Closest Location

Site 10-105 - Murfreesboro, TN

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of moderate to sever facial acne vulgaris
Facial IGA score of 3 (moderate) or 4 (severe)
At least 20 and no more than 100 inflammatory lesions on the face
No more than 100 noninflammatory lesions on the face.
No more than 5 nodules (≥5 mm) on the face

Patient Q&A Section

What are the signs of acne?

"Acne has various signs and symptoms, which can be identified by a simple questionnaire. Knowledge of symptoms also aids a diagnosis of other diseases that may coexist with, or be a contributing factor in, acne. We recommend this questionnaire for use when evaluating acne patients." - Anonymous Online Contributor

Unverified Answer

What is acne?

"Patients need to learn that acne is a chronic skin infection caused by abnormal production of sebum by sebaceous glands in certain areas of the skin. And unlike acne vulgaris, acne does not have immediate consequences in the form of visible bumps, scars, and discoloration. There is a need for increased awareness of the chronic nature of this skin condition, and for patients to be aware that once the infection has cleared, the skin returns to normal. One aspect of this disease is the necessity for self-analysis of one's own skin and hair condition, as many patients only discover the nature of their condition after a protracted course of antibiotics and oral retinoids." - Anonymous Online Contributor

Unverified Answer

What causes acne?

"Acne is caused by a combination of the amount of oil and the quantity of bacteria and their virulence factors produced by the follicle. Skin color and body weight are important factors in the development of oily skin. Acne will resolve if the oily skin problem is addressed." - Anonymous Online Contributor

Unverified Answer

What are common treatments for acne?

"There are often multiple treatments for acne, depending on its severity and the patient's willingness to try different treatments. Treatment may include prescription and OTC drugs, creams, keratoconjuctivs, and salons. Treatment is typically tailored to the treatment and severity of the patient's acne." - Anonymous Online Contributor

Unverified Answer

Can acne be cured?

"There is currently no evidence that acne can be fixed or erased from a person's skin, but there is a growing belief that acne can be substantially reduced by medication." - Anonymous Online Contributor

Unverified Answer

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

"In a recent study, findings, acne affected 1% to 12% of people, according to the duration of the disease. About 7% of patients treated for acne had the disease for more than 5 years. The prevalence of acne decreased with age, and patients aged 75 years or older are less likely to have the disease, and the severity of it, but not of the disease." - Anonymous Online Contributor

Unverified Answer

Does acne run in families?

"There was no increased prevalence of acne in both parents, siblings, or other relatives of affected cases. This suggests that acne does not run in families." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of imsidolimab?

"The most common drug-related side effects of imsidolimab are rash, fever and upper respiratory tract infections. Most of the drugs commonly reported to cause rashes were not reported as side effects of imsidolimab. In addition, no serious hypersensitivity reactions were reported with regards to imsidolimab. Imsidolimab should be avoided in patients with a history of interstitial lung disease of pregnancy. Patients treated with imsidolomab should be closely monitored for potential side effects, including an increased risk for infections, with particular attention to opportunistic infections, due to drug-induced immunosuppression." - Anonymous Online Contributor

Unverified Answer

What is imsidolimab?

"Imsidolimab is an antibody for TNF-α and has been used in patients with Crohn's disease, psoriasis, psoriatic arthritis, ulcerative colitis, rheumatoid arthritis, and uveitis. For its ability to modulate the expression of inflammatory mediators and adhesion molecules, such as chemokines and integrins, it could be a useful drug for the treatment of rheumatic and other immune-mediated disorders." - Anonymous Online Contributor

Unverified Answer

Has imsidolimab proven to be more effective than a placebo?

"Recent findings obtained in subjects with more moderate to severe acne indicated that IM was more effective than placebo in inducing a faster clinical response (greater decrease of acne erythema), more rapid and extensive clearance and an earlier termination of the acne exacerbations." - Anonymous Online Contributor

Unverified Answer

Does imsidolimab improve quality of life for those with acne?

"In a recent study, findings, imsidolimab did not demonstrate a significant reduction in QoL for patients with acne and should be considered as a second-line drug of treatment for this disease. These preliminary results should be considered in assessing the value of imsidolimab for this indication in the light of the recent literature." - Anonymous Online Contributor

Unverified Answer

How does imsidolimab work?

"‘ImmD0’ shows activity with a safety profile similar to other CD20 inhibitors. Its mechanism of action is a unique CD20-independent signalling pathway, and the results confirm the potential of imsidolimib for treatment." - 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.
See if you qualify for this trial
Get access to this novel treatment for Acne by sharing your contact details with the study coordinator.