A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy (SUMMIT)

ALK-Abelló

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Biological: SLITone ULTRA HDM immunotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01728298

SU-M-01

Details and patient eligibility

About

The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 or older
• Moderate to severe persistent HDM allergic rhinitis with or without asthma
• Moderate to severe HDM allergic rhinitis symptoms during a baseline period
• Positive skin prick test response (wheal diameter ≥ 3 mm)
• Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l)

Exclusion criteria

• Previous treatment with immunotherapy with House dust mite immunotherapy
• Ongoing treatment with any allergen specific immunotherapy product
• Reduced lung function
• Clinical history of uncontrolled asthma
• Inflammatory conditions in the oral cavity with severe symptoms
• History of anaphylaxis with cardiorespiratory symptoms
• History of recurrent generalised urticaria
• A history of drug induced facial angioedema or hereditary angiooedema
• Any clinically relevant chronic disease (≥3 months duration)
• Systemic disease affecting the immune system
• Immunosuppressive treatment
• Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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219 participants in 3 patient groups

SLITone ULTRA low dose

Active Comparator group

Description:

SLITone ULTRA HDM immunotherapy

Treatment:

Biological: SLITone ULTRA HDM immunotherapy

SLITone ULTRA medium dose

Active Comparator group

Description:

SLITone ULTRA HDM immunotherapy

Treatment:

Biological: SLITone ULTRA HDM immunotherapy

SLITone ULTRA high dose

Active Comparator group

Description:

SLITone ULTRA HDM immunotherapy

Treatment:

Biological: SLITone ULTRA HDM immunotherapy