16 Participants NeededMy employer runs this trial

Cat Allergen Immunotherapy for Allergy

(LYNX Trial)

TM
Overseen ByTanya M Laidlaw, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Subcutaneous immunotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of cat allergen immunotherapy on individuals allergic to cats. It examines whether exposure to cat allergens alters the types of immune cells in participants' bodies by comparing those already receiving treatment to those who are not. The study includes two groups: one group has undergone subcutaneous immunotherapy (shots under the skin) for at least a year, while the other group has never received such treatment. Ideal participants have moderate to severe cat allergies that disrupt daily life or sleep but do not suffer from severe asthma or frequent sinus infections. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking allergy research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are in the No immunotherapy cohort, you cannot be on any form of allergen immunotherapy. Also, certain medications like systemic corticosteroids and immunosuppressants should not have been used recently before screening.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cat allergen immunotherapy, specifically subcutaneous immunotherapy (SCIT), is generally safe. Most side effects are mild and occur at the injection site, such as redness or swelling. For example, one study found that using a modified cat allergen in SCIT mainly caused mild, delayed reactions at the injection site. Another study highlighted that a product called Dpg-pol-cat used in SCIT had an excellent safety record, making it a good option for treating cat allergies.

Additionally, some patients have used SCIT for over a year with positive results, demonstrating its tolerance over time. This ongoing use of SCIT in treating cat allergies supports its safety for those considering joining a clinical trial.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for cat allergies, which typically involve antihistamines or corticosteroids to manage symptoms, Cat Allergen Immunotherapy aims to address the root cause of the allergy by gradually desensitizing the immune system to cat allergens. Researchers are excited about this approach because it has the potential to provide long-term relief, reducing the need for ongoing medication. This therapy uses precise allergen exposure to train the immune system, which is different from traditional methods that primarily focus on symptom control.

What evidence suggests that this trial's treatments could be effective for cat allergy?

Research has shown that subcutaneous immunotherapy (SCIT) for cat allergies can effectively reduce symptoms. One study demonstrated that SCIT greatly improved quality of life and decreased the need for medication in people with moderate to severe cat allergies. Another study found that after 12 months of treatment, patients were very satisfied and experienced fewer allergic reactions. In this trial, participants in the SCIT cohort will have been on maintenance dosing for at least one year. SCIT works by gradually helping the body get used to cat allergens, which trigger allergies. The treatment is generally safe, with most side effects being mild, such as swelling at the injection site.12367

Who Is on the Research Team?

CB

Carolyn Baloh, M.D.

Principal Investigator

Brigham and Women's Hospital: Division of Allergy and Clinical Immunology

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe cat allergies that affect daily life or sleep. Participants must show a strong allergic reaction to cats on tests, be able to give consent, and women of childbearing age need a negative pregnancy test. Some participants must have had at least 1 year of ongoing cat allergy shots.

Inclusion Criteria

I have moderate to severe allergy symptoms from cats that affect my daily life or sleep.
3. Skin prick test wheal greater than or equal to 5 mm to standardized cat extract or cat-specific IgE greater than or equal to 0.7 kU/L obtained within 5 years of screening. These can be obtained from medical records if available from the prior 5 years, or at the screening visit if not
I am a woman who can become pregnant and my pregnancy test is negative.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo intradermal cat allergen challenge in bilateral upper arms

1 day
1 visit (in-person)

Sampling Phase 1

Axillary lymph node and peripheral blood sampling

3 days
1 visit (in-person)

Sampling Phase 2

Axillary lymph node, peripheral blood, and adenoid and nasal sampling

3 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cat Allergen Immunotherapy

Trial Overview

The study compares two groups: one receiving regular cat allergy shots (immunotherapy) and one not. Both groups will get small injections of cat allergen in the arms, followed by blood and lymph node sampling over three weeks to see immune cell responses.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Subcutaneous Immunotherapy (SCIT) cohortExperimental Treatment1 Intervention
Group II: No immunotherapy (IT) CohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

Effectiveness and safety of subcutaneous immunotherapy ...

SCIT with Dpg-pol-cat proved to be effective with an excellent safety profile in this real-world study, making it a good treatment option for ...

Effectiveness and safety of subcutaneous immunotherapy ...

Subcutaneous immunotherapy with a depigmented cat allergoid in patients with cat allergy is safe and results primarily in delayed local reactions [D3.209].

Patient characteristics and treatment satisfaction with 300 ...

The results here suggest high satisfaction of patients with cat allergy improved since treatment initiation and observed at 6 months and 12 months. This survey ...

497 Effectiveness of subcutaneous immunotherapy

RATIONALE: Cat dander allergy is a common trigger of allergic rhinitis and ... RESULTS: A total of 94 adults received dpg-pol cat SCIT. At 12 months ...

Cat Allergen Immunotherapy Shows Real-World ...

Subcutaneous Dpg-pol-cat significantly improved the quality of life and reduced medication use in adults with moderate to severe cat allergy.

NCT06960382 | Safety and Immunogenicity of Cat-allergen ...

The main outcome measures on the safety, tolerability, immunogenicity and efficacy. The data will be used to design later efficacy studies. Safety is measured ...

Real Life Study Of Safety and Efficacy Of Subcutaneous ...

Conclusions. SCIT with Alutard SQ®(ALK-Abelló) from cat or dog has demonstrated clinical efficacy and can be considered safe.