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Study of IM-250 capsules compared to placebo in patients with recurrent genital herpes

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with recurrent genital herpes, a recurring viral infection that causes outbreaks of sores in the genital area. The study evaluates a new medication called IM-250, which is given as oral capsules once per week. The purpose is to determine if this new treatment can help control herpes outbreaks when used as a long-term preventive therapy.

The research involves testing different doses of IM-250 against a placebo to understand how well the medication works and how safe it is. The study is conducted in a double-blind manner, which means neither the patients nor the doctors know who receives which treatment during the study. Participants will take either the study medication or placebo weekly for several weeks.

During the trial, doctors will monitor how often participants experience viral shedding (when the virus becomes active and potentially contagious) and track the occurrence of herpes outbreaks. They will also study how the medication moves through the body and how long it remains active. The study includes regular check-ups and testing to ensure participant safety throughout the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial phase
You will receive a weekly oral dose of either IM-250 50mg capsules or placebo (an inactive substance).
The study is double-blind, which means neither you nor the medical staff will know which treatment you are receiving.
If you are currently taking antiviral medication, you must stop taking it at least 14 days before starting the study medication.
Step 2
Daily monitoring
You will need to collect daily genital swabs for laboratory testing.
You will need to keep track of any genital lesions that appear during the study period.
The monitoring will continue for 56 days after receiving the first dose of study medication.
Step 3
First 28 days assessment
The medical team will evaluate how often genital lesions appeared during the first 28 days of treatment.
Laboratory tests will check for the presence of the herpes virus in your swab samples.
Step 4
Complete 56 days assessment
The medical team will evaluate how often genital lesions appeared during the entire 56-day period.
Laboratory tests will continue to check for the presence of the herpes virus in your swab samples.
Blood samples will be taken to measure the levels of study medication in your body.
Step 5
Study completion
The study will evaluate how the medication affects the frequency of virus presence and genital lesions.
The study will compare results between participants who received different doses of IM-250 and those who received placebo.

Who can join the trial?

9 criteria

Must be between 18 and 65 years old when giving consent to participate
Both men and women can participate if they agree to follow the study's contraceptive requirements
Must have a history of genital herpes (HSV-2) for at least 12 months before screening, confirmed by laboratory tests (PCR, cell culture, or antibody test)
check
For patients currently taking suppression medication:
- Must have had 3-9 outbreaks in the 12 months before starting suppression therapy
- Must stop taking current suppression medication at least 14 days before starting study treatment
- check
  For patients not taking suppression medication:
  - Must have had 3-9 episodes with visible symptoms in the past 12 months
  - Must be willing to stop using any antiviral treatments (taken by mouth or applied to skin) at least 14 days before starting study medication
  - Must be able and willing to follow all study requirements and restrictions
  - Must be able to understand and provide written informed consent to participate in the study

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Pregnant or breastfeeding women
History of allergic reactions to similar medications
Active immunosuppression (weakened immune system) due to medications or medical conditions
Severe kidney or liver disease
Current participation in other clinical trials
Unable to follow study procedures or attend scheduled visits
History of drug or alcohol abuse within the past year
Uncontrolled medical conditions such as diabetes or high blood pressure
Use of medications that could interact with the study drug
Mental health conditions that could affect ability to provide informed consent
Active infections other than genital herpes
Previous adverse reactions to similar antiviral medications
History of significant heart problems or abnormal heart rhythm
Unable to practice effective contraception during the study period

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Diagnostics And Consultation Center Convex Ltd.
Sofia, Bulgaria
Verified
Kliiniliste Uuringute Keskus OÜ
Tartu, Estonia

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Investigated drugs

IM-250 is an investigational medication being studied for the treatment of recurrent genital herpes. It is administered weekly and is being tested as a suppressive therapy, which means it's intended to help prevent or reduce the frequency of herpes outbreaks. This is a new drug that is still known by its development code name and is being evaluated for its safety and effectiveness in patients who experience recurring episodes of genital herpes.

(S)-2-(2',5'-DIFLUORO-[1,1'-BIPHENYL]-4-YL)-N-METHYL-N-(4-METHYL-5-(S-METHYLSULFONIMIDOYL)THIAZOL-2-YL)ACETAMIDE

What is already known about the treatment

IM-250 - An investigational medication being studied in clinical trials for the treatment of recurrent genital herpes through weekly administration. This drug is currently in Phase 1b/2a testing, where researchers are evaluating its safety profile and potential effectiveness as a suppressive therapy for herpes infections. While the exact molecular mechanism is still under investigation as part of the clinical trials, the medication is being developed specifically for immune-mediated control of herpes virus outbreaks. The weekly administration schedule represents a potential advantage over existing daily therapies for genital herpes management.

Investigated diseases

Genital Herpes - A viral infection caused by the herpes simplex virus (HSV) that affects the genital area. The virus establishes itself in the body's nerve cells, where it can remain dormant between outbreaks. When active, it typically causes small, painful blisters or sores in the genital region. The condition often cycles between periods of active symptoms and dormancy. Initial infection may be accompanied by flu-like symptoms, and subsequent outbreaks are usually milder. The virus can spread through direct skin contact, even when no visible symptoms are present.