Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients

Raphas

Status and phase: Invitation-only; Phase 1

Conditions: House Dust Mite Rhinitis; Mite Allergy; Rhinitis, Allergic

Treatments: Drug: House Dust Mite Extract, Dermatophagoides Farinae

Study type: Interventional

Funder types: Industry

Identifiers

NCT05525650

RapMed 1506-11-A

Details and patient eligibility

About

When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.

Enrollment: 54 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen.
• ImmunoCAP® titer > 3.49 kUA/L for the house dust mite antigen.
• Determined to be suitable for clinical trials as a result of laboratory tests.

Exclusion criteria

• Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines.
• In case of lactation or pregnancy.
• If an infectious disease that may affect this study is identified.
• Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug.
• If the allergy skin prick test is negative for the house dust mite antigen.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 6 patient groups, including a placebo group

1Arm A

Experimental group

Description:

As the maintenance UNIT, 200 PAU

Treatment:

Drug: House Dust Mite Extract, Dermatophagoides Farinae

1Arm B

Placebo Comparator group

Description:

Placebo arm of 1Arm A.

Treatment:

Drug: House Dust Mite Extract, Dermatophagoides Farinae

2Arm C

Experimental group

Description:

As the maintenance UNIT, 400 PAU

Treatment:

Drug: House Dust Mite Extract, Dermatophagoides Farinae

2Arm D

Placebo Comparator group

Description:

Placebo arm of 2Arm C.

Treatment:

Drug: House Dust Mite Extract, Dermatophagoides Farinae

3Arm E

Experimental group

Description:

As the maintenance UNIT, 800 PAU

Treatment:

Drug: House Dust Mite Extract, Dermatophagoides Farinae

3Arm F

Placebo Comparator group

Description:

Placebo arm of 3Arm E.

Treatment:

Drug: House Dust Mite Extract, Dermatophagoides Farinae