Recruiting PHASE4 Allergic Rhinitis

New treatment option for Allergic Rhinitis

Official title Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice

ClinicalTrials.gov ID: NCT07651891

What this study is testing

What is ALK Alutard SQ Dog?

ALK Alutard SQ Dog is an investigational medicine, being studied as a potential treatment for allergic rhinitis.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
STUDY DESIGN A single-center prospective before-and-after study evaluating the effect of Alutard SQ Dog in 40 men and women with moderate-to-severe dog allergy. Participants will serve as their own controls.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 50

You may be able to join if

  • The subject has provided written informed consent to participate in the study.
  • Age 18-50 years.
  • Moderate-to-severe allergic symptoms upon exposure to dogs.
  • Dog allergy confirmed by positive specific IgE.
  • Considered suitable by the investigator for treatment with Alutard SQ Dog in accordance with the approved Summary of Product Characteristics (SmPC).

You likely can't join if

  • Pregnancy or breastfeeding.
  • Autoimmune or connective tissue disease.
  • Cardiovascular disease.
  • Hepatic disease.
  • Renal disease.
  • Malignancy.
See the full eligibility criteria
Who can join
  • The subject has provided written informed consent to participate in the study.
  • Age 18-50 years.
  • Moderate-to-severe allergic symptoms upon exposure to dogs.
  • Dog allergy confirmed by positive specific IgE.
  • Considered suitable by the investigator for treatment with Alutard SQ Dog in accordance with the approved Summary of Product Characteristics (SmPC).
  • Female people of childbearing potential must use adequate contraception.
  • A negative pregnancy test must be obtained prior to enrolment.
What rules you out
  • Pregnancy or breastfeeding.
  • Autoimmune or connective tissue disease.
  • Cardiovascular disease.
  • Hepatic disease.
  • Renal disease.
  • Malignancy.
  • Upper airway disease (e.g., non-allergic sinusitis or nasal polyposis).
  • Chronic obstructive or restrictive lung disease.
  • Treatment with medications that may interfere with the immune response.
  • Previous immunotherapy or chemotherapy.
  • Significant chronic disease.
  • Major metabolic disease.
  • Alcohol or substance abuse.
  • Mental or cognitive incapacity that may impair compliance with study procedures.
  • Known or suspected hypersensitivity to the study product.
  • Suspected or confirmed bacterial infection.
  • Clinically relevant allergy to house dust mite.
  • Current dog ownership.
  • Any condition that, in the investigator's opinion, may make participation, follow-up, or study assessments inappropriate.
  • Any subject considered unsuitable for enrolment according to the principles of the Declaration of Helsinki.

The study team makes the final eligibility decision.

Where it's taking place

  • Lund, Skåne County, Sweden
  • Trelleborg, Skåne County, Sweden

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Lund, Skåne County, Sweden; Trelleborg, Skåne County, Sweden. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.