Mast Cell Stabilizers for Post-tick Bite Illness

Overseen By Julie Vorobiov

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Omalizumab, Systemic steroids, Zileuton

Disqualifiers: Pregnancy, Suicidal ideation, Unstable illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase II double-blinded study to assess the safety, tolerability, and feasibility of the mast cell stabilizing medications ketotifen and cromolyn compared to participants receiving standard of care treatment with fexofenadine alone in participants who have persistent symptoms of mast cell activation following a documented tick-borne illness (Ehrlichiosis, Rocky Mountain Spotted Fever, Alpha-gal Syndrome).

Who Is on the Research Team?

Scott Commins

Principal Investigator

University of North Carolina

Are You a Good Fit for This Trial?

Inclusion Criteria

* OR - History of alpha-gal syndrome (AGS) with an alpha-gal Immunoglobulin E (IgE) \>0.1 IU/mL and managed on an appropriate avoidance diet for more than 6 months previously with current symptoms causing clinically significant distress or impairment in functioning as measured by a mast cell symptom scale score \>88 ± 9

I am a woman who can become pregnant and have tested negative for pregnancy.

I am able to avoid taking Benadryl during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in Period

Participants receive fexofenadine for 14 days to assess symptom improvement

2 weeks

1 visit (in-person)

Treatment

Randomized participants receive either fexofenadine alone or a combination of ketotifen, cromolyn, and fexofenadine for 4 months

4 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cromolyn Sodium
• Ketotifen

How Is the Trial Designed?

Group I: Mast Cell-Directed Combination Therapy Experimental Treatment 3 Interventions

Participants receive ketotifen plus cromolyn plus fexofenadine for 4 months following a 14-day open-label run-in period. Ketotifen is administered orally at 1 mg twice daily with dose escalation to 2 mg twice daily after 30 days. Cromolyn is administered orally at 200 mg three times daily, and fexofenadine is administered orally at 180 mg once daily.

Group II: Fexofenadine Monotherapy Active Control 1 Intervention

Participants receive fexofenadine 180 mg orally once daily for 4 months following a 14-day open-label run-in period

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+