Phase II study to assess the tolerability, safety and efficacy of subcutaneous cluster-immunotherapy in patients suffering from house dust mite allergy

Phase II study to assess the tolerability, safety and efficacy of subcutaneous cluster-immunotherapy in patients suffering from house dust mite allergy - Tolerability and efficacy of CLUSTOID mite extract

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002317-10-DE

Enrollment

165

Registered

2017-12-11

Start date

2019-04-17

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis / rhino-conjunctivitis MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 20.0 Level: LLT Classification code 10020419 Term: House dust mite allergy System Organ Class: 100000004870 MedDRA version: 21.1 Level: LLT Classification code 10034382 Term: Perennial allergic rhinitis System Organ Class: 100000004855

Interventions

Product Name: CLUSTOID D. pteronyssinus Pharmaceutical Form: Suspension for injection INN or Proposed INN: CLUSTOID D. pteronyssinus Other descriptive name: Modified allergen extract of Dermatophagoid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Signed and dated patient's informed consent obtained prior to any study specific examination • Female or male patients aged 18-65 at the time of informed consent • History of allergic rhinitis / rhinoconjunctivitis due to house dust mites with or without well controlled asthma according to GINA guideline (Global Initiative for Asthma, 2017) for at least 1 year • Sensitization to Dermatophagoides pteronyssinus, verified by: - positive skin prick test (wheal diameter = 3 mm and negative control =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: • Previous immunotherapy with allergen extract of house dust mites according to the homologous group of the Dermatophagoides genus in Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831) within the last 5 years • Simultaneous participation in other clinical trials • Simultaneous specific immunotherapy with other allergens • Usual contraindications for SCIT • History of anaphylaxis • Any severe or unstable lung disease e. g. active tuberculosis, cystic fibrosis, COPD • Irreversible secondary disorders of the target organs (e. g. emphysema, bronchoectasis) • Completed or ongoing treatment with anti-IgE-antibody • Diseases of the immune system including autoimmune and immune deficiencies • Severe acute or chronic inflammatory or infectious diseases • Existing or intended pregnancy, lactation or inadequate contraceptive measures for woman with childbearing potential or a positive pregnancy test at screening • Systemic and local (eye drops) treatment with beta-blockers • Partly controlled or uncontrolled asthma according to GINA guideline (Global Initiative for Asthma, 2017). • Contraindication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism, glaucoma) • Relationship or dependence with the sponsor and/or investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of four different doses of CLUSTOID® D. pteronyssinus compared to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five trial groups.;Secondary Objective: To assess the tolerability and safety of four different doses of CLUSTOID® D. pteronyssinus compared to placebo by occurrence of treatment-related adverse events.;Primary end point(s): To assess the efficacy of four different doses of CLUSTOID® D. pteronyssinus compared to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five trial groups.;Timepoint(s) of evaluation of this end point: 7 months after start of the study	—

Measure

Time frame

Main Objective: To assess the efficacy of four different doses of CLUSTOID® D. pteronyssinus compared to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five trial groups.;Secondary Objective: To assess the tolerability and safety of four different doses of CLUSTOID® D. pteronyssinus compared to placebo by occurrence of treatment-related adverse events.;Primary end point(s): To assess the efficacy of four different doses of CLUSTOID® D. pteronyssinus compared to placebo. The primary efficacy endpoint is defined as percentage of patients with an increased dosing step needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the five trial groups.;Timepoint(s) of evaluation of this end point: 7 months after start of the study

—

Secondary

Measure	Time frame
Secondary end point(s): To assess the tolerability and safety of four different doses of CLUSTOID® D. pteronyssinus compared to placebo by occurrence of treatment-related adverse events.;Timepoint(s) of evaluation of this end point: 7 months after start of the study	—

Countries

Germany

Contacts

Public ContactROXALL Medizin GmbH

ROXALL Medizin GmbH

ct@roxall.de0049408972520

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026