LOOKING CLOSER AT LYME DISEASE

Tick exposure doesn’t
only happen at campsites

The CALLIOPE clinical study
is researching a potential drug for
Lyme disease prevention.

Get started now

If you are 18+ years old, you may be eligible to participate. Potential benefits for participating include:

  • Compensation for study-related expenses.
  • No-cost study-related care.
  • No-cost study drug.

If you are 18+ years old, you may be eligible to participate. Potential benefits for participating include:

  • Compensation for study-related expenses.
  • No-cost study-related care.
  • No-cost study drug.

GET THE FACTS

Lyme disease is the most common vector-borne disease in the United States and is caused by a tick bite. They can be present when spending time near woods or forests, but they can also appear in urban places like local parks, yards, and greenways.1

Over 470,000 Lyme disease cases are diagnosed each year in the US.2

~90% of all Lyme disease cases in the US are reported from the Northeast, mid-Atlantic, and upper-Midwest regions.3

TP-05 (lotilaner) is currently being studied to see if it can kill ticks to prevent Lyme disease. Lotilaner belongs to a group of drugs that target and affect bugs like ticks, but not humans.4

Participation in this study lasts up to 15 months with a maximum of 13 on-site study visits. Participants will be divided into 3 groups and will have a 66% chance of getting the study drug.

Participants can withdraw from the study at any time and for any reason.

All about the CALLIOPE study

This is a Phase 2b study to assess the safety and efficacy of 2 dosing regimens of TP-05 (lotilaner) in participants at high risk of tick exposure.

If you qualify and decide to participate, you will be randomly assigned to one of three groups where you may receive:
  • Study drug with Dose Regimen A.
  • Study drug with Dose Regimen B.
  • Placebo.
You will need to take the study drug or placebo every 4 weeks for a total of 6 times.
See if you qualify

The study will consist of the following periods:

A 28-day Screening/Run-in Period to make sure you are fit for the study.

A 24-week Study Treatment Period where you will be randomly assigned to receive either the study drug or placebo.

A 35-week Follow-up Period where we will assess the safety of the study treatment.

Frequently Asked Questions

Researchers can conduct clinical studies, also known as clinical trials, to learn if an investigational medication is safe and effective for people who have certain health conditions. Clinical studies follow strict scientific standards and FDA regulations to reduce the risk to participants and produce quality data for health care decision making.

When new drugs are being studied as possible treatments for patients with a disease, they are tested in stages, or “phases.” If a drug is successful during Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

A Phase 2b trial tests the same drug from Phase 1, but on a larger group of people. This allows for more data on a larger scale to see if the drug is safe and potentially works. It helps find the preferred dose and checks for any side effects.

Source: U.S. Food and Drug Administration. (n.d.). Step 3: Clinical research. FDA. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research

The main goal of the study is to investigate how TP-05 works in preventing Lyme disease in participants at high risk of tick exposure.

In early clinical studies:

  • No serious adverse reactions were found
  • Most common drug-related adverse reaction: headache

Yes, you have the right to drop out of the trial at any time for any reason, or no reason at all.

To join this study, you must read and sign an informed consent document to show that you understand the study and what is required and qualify. A study team member will explain the study’s procedures, possible benefits and risks, and answer any questions you may have prior to you signing the form.

Taking TP-05 is simple

In the CALLIOPE study, TP-05 is given as an oral medicine, meaning you swallow it.

Find a participating site or visit ClinicalTrials.gov to learn more about the study.

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1 Gregory, N., Fernandez, M.P. & Diuk-Wasser, M. Risk of tick-borne pathogen spillover into urban yards in New York City. Parasites Vectors 15, 288 (2022). https://doi.org/10.1186/s13071-022-05416-2

2 Centers for Disease Control and Prevention. (2025, March 13). Lyme disease surveillance and data. U.S. Department of Health & Human Services. https://www.cdc.gov/lyme/data-research/facts-stats/index.html

3 Kugeler, K. J., Earley, A., Mead, P. S., & Hinckley, A. F. (2024). Surveillance for Lyme disease after implementation of a revised case definition — United States, 2022 (Vol. 73, No. 6, pp. 118–123). Morbidity and Mortality Weekly Report. Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/73/wr/pdfs/mm7306-H.pdf

4 Tarsus Pharmaceuticals, Inc. (2023). XDEMVY™ (lotilaner ophthalmic solution) prescribing information (Revised July 2023) [PDF]. https://tarsusrx.com/wp-content/uploads/XDEMVY-Prescribing-Information-24JUL23.pdf