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

1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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)
  • 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
  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
01.11.2024

Trial locations

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.

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.

Trial ID:
2024-516368-27-00
Protocol code:
IM-202
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • Study on the Safety and Effects of VERT-002 for Patients with Advanced Solid Tumors, Including Lung Cancer with MET Alterations

    Recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain
  • Evaluation of mRNA-4359 Monotherapy and Combined Pembrolizumab Therapy in Advanced Solid Tumors: A Phase 1/2 Clinical Trial

    Recruiting

    1 1 1
    Germany Italy Poland Spain