Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

NCT01489020 | Completed Phase 1 Results

• 2 other identifiers: BIA-DPT-P1-0012009-016277-15
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergy; Immunotherapy; Allergic Rhinoconjunctivitis; D. pteronyssinus; house dust allergy

Outcome Measures

Primary Outcomes (1)

• Number and Seriousness of Both Local and Systemic Adverse Reactions

  The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).

  From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )

Secondary Outcomes (3)

• Immunoglobulin Levels (IgE Specific) Active Versus Placebo

  Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)

• Immunoglobulin Levels (IgG Total) Active Versus Placebo

  Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)

• Immunoglobulin Levels (IgG 4) Active Versus Placebo

  Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)

Study Arms (6)

Group A active

EXPERIMENTAL

6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.

Biological: subcutaneous immunotherapy with DPT extract

Group A placebo

PLACEBO COMPARATOR

6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.

Biological: Subcutaneous depot placebo

group B active

EXPERIMENTAL

8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals

Biological: subcutaneous immunotherapy with DPT extract

Group B placebo

PLACEBO COMPARATOR

8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals

Biological: Subcutaneous depot placebo

Group C active

EXPERIMENTAL

8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval

Biological: subcutaneous immunotherapy with DPT extract

Group C placebo

PLACEBO COMPARATOR

8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval

Biological: Subcutaneous depot placebo

Interventions

subcutaneous immunotherapy with DPT extract BIOLOGICAL

Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)

Also known as: DPT depot vaccine

Group A active; Group C active; group B active

Subcutaneous depot placebo BIOLOGICAL

Increasing doses of subcutaneous depot placebo in three different scales

Group A placebo; Group B placebo; Group C placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
• Patients must sign the informed consent form.
• Patients must be between 18 and 60 years of age.
• Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to DPT.
• Patients will preferably be monosensitized to DPT. In the case of polysensitized patients they can only be included if other sensitizations are caused by seasonal allergens whose pollination do not overlap with the study period.
• Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
• Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active

You may not qualify if:

• Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
• Patients who received immunotherapy in the previous 5 years for DPT or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
• Patients with severe asthma or FEV1 minor than 70% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment initiation.
• Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
• Patients with a previous history of anaphylaxis
• Patients with chronic urticaria
• Patients with unstable angina
• Patients with uncontrolled hypertension
• Patients with clinically significant arrythmias
• Patients with neoplasia
• Patients with clinically relevant malformations of the upper respiratory tract.
• Other chronic or immunological disease that could interfere with the assessment of the investigational product or that could generate any additional risk for the patients
• Patients who have participated in another clinical trial within 3 month prior to enrolment.
• Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
• Female patients who are pregnant or breast-feeding or women of childbearing potential that do not agree to use an appropriate contraception method during the study if they are sexually active, if they have not been surgically sterilised or present any other incapacity to bear

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (2)

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital La Fe

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Limitations and Caveats

Sample size

Results Point of Contact

• Title: Dr. M Cruz Gómez project manager of Roxall Medicina España S.A.
• Organization: Roxall Medicina España S.A.

maricruz.gomez@roxall.es

+34 944438000

Study Officials

• Mª Dolores Hernández, MD

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

• Ignacio Antépara, MD

  Hospital de Basurto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 9, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-01

Locations

ES (2)