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A Novel Biologic Therapy for Perennial Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Allergen Immunotherapy Extract

Allergen Immunotherapy Control

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The subject is a male or a non-pregnant, non-lactating female between the ages of 18 and 65.
The subject is actively manifesting symptoms and signs of moderate to severe Perennial Allergic Rhinitis (PAR) with or without Seasonal Allergic Rhinitis (SAR) component defined as score of at least 28 on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and 6 on the Total Nasal Symptom Score (TNSS) scale. Scores will be determined on the first and second visit (after the 14 day medication washout period). Both scores exceeding their threshold on either day will qualify.
Skin test strongly positive (wheal at least 5mm diameter and 2mm greater than negative control) to at least 6 of 48 allergy skin prick tests including at least one species of dust mite.

Exclusion Criteria:

The subject has received any investigational compound within 30 days prior to screening.
The subject has received allergen immunotherapy or Sublingual immunotherapy (SLIT) in a previous clinical study or as a therapeutic agent within the past two years.
The subject has a history or clinical manifestations of significant medical conditions (cardiovascular, hepatic, infectious or renal disease, etc.) which in the opinion of the investigator renders them unacceptable study subjects.
The subject has a history of drug abuse (defined as any chronic illicit drug use) or a history of alcohol abuse within 5 years prior to the screening visit.
The subject is required to take excluded medications listed in Section 6.3.
If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
Subjects found to have on physical exam significant nasal polyps, septal deviation or infectious sinusitis.
The subject has a history of allergic rhinitis but is not currently manifesting active signs and symptoms of the disorder.
Subject has a history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening. (A history of treated Cervical Intraepithelial Neoplasia (CIN) I, II, or CIN III is allowed.)

Sites / Locations

Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Allergen Immunotherapy Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Daily Combined Score (DCS)

Change in baseline. TNSS (Total Nasal Symptoms Score) + medication rescue score. TNSS is a scale of 0-12 with 12 being severe. Medication score is also 0-12 with 12 being highest use of medications. Thus DCS ranges from 0-24 (severe).

Mini RQLQ

mini-RQLQ (mini-Rhinoconjunctivitis Quality of Life Questionnaire) is to measure a the level of severity of a set of symptoms of functional impairments due to rhinoconjunctivitis from baseline. 14 questions each range 0-6 (6 is most severe). Total range 0-84 (higher value is more severe symptoms).

Secondary Outcome Measures

Rescue Medication Use

Use of epinephrine during intervention for a total of 8 weeks through followup and study completion (4 more weeks). Thus total number of times epinephrine is required per patient during entire 12 week period.

Safety Assessment

Safety and adverse events (AES) will be followed. We will measure and report systemic reactions.

Full Information

NCT ID

NCT03360071

First Posted

November 21, 2017

Last Updated

August 14, 2019

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT03360071

Brief Title

A Novel Biologic Therapy for Perennial Allergic Rhinitis

Official Title

A Double-blind, Prospective, Parallel Group Evaluation of a Novel Biologic Therapy for Perennial Allergic Rhinitis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

December 19, 2016 (Actual)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept study which will evaluate the effect of a preparation of FDA approved allergens (PMA) used as a sub-cutaneously administered immunotherapy for the management of allergic rhinitis (perennial and seasonal).

Detailed Description

This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept study which will evaluate the effect of a proprietory mixed preparation of FDA approved allergens (PMA) used as a sub-cutaneously administered immunotherapy for the management of allergic rhinitis (perennial and seasonal). Participating study subjects will be required to manifest the signs and symptoms of allergic rhinitis and test positive to at least six allergens using a multi aeroallergen screen at the time of study recruitment . All subjects will undergo standard allergen skin prick testing using six Multi-Test® PC skin prick test devices (Lincoln Diagnostics, Decator, IL) or comparable skin testing technique for a total of 48 Skin Prick Test (SPT). Approximately 36 total subjects will be enrolled. Following a successful screening study visit and two week medication washout period, a 8 week treatment period will be initiated with bi-weekly study visits being undertaken, through to the end of immunotherapy, for assessment of therapeutic response and safety evaluations. Efficacy evaluation will be monitored using validated instruments that assess study subject clinical response, physician global assessment, and medication use. A safety assessment will be undertaken one month following completion of treatment. At the screening visit (Screening Visit) a potential study subject will be required to fulfill the requirements of the study inclusion and exclusion criteria, will have a clinical evaluation including medical history and physical examination, blood draw and performance of skin testing. The study subject will then abstain from using intranasal steroids and antihistamines for two weeks and then return to the clinic for administration of sub-cutaneous PMA and post-treatment in-clinic safety evaluation. The latter evaluation period will comprise approximately 60 minutes to assess the study subject's response to PMA immunotherapy. Follow up clinic study visits will continue bi-weekly through 8 weeks and at each of these visits the study subject will receive increasing doses of PMA immunotherapy and will be evaluated for safety. Twice weekly clinical evaluation will also be performed. Following the final administration of PMA immunotherapy, a one month follow-up safety and clinical efficacy evaluation will be conducted by telephone or in the clinic. The duration of the study will be approximately 14 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allergen Immunotherapy Group

Arm Type

Experimental

Arm Title

Control Group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Allergen Immunotherapy Extract

Intervention Description

Allergen Immunotherapy treatment mixture to be delivered subcutaneously

Intervention Type

Drug

Intervention Name(s)

Allergen Immunotherapy Control

Intervention Description

Allergen Immunotherapy Control Solution to be delivered subcutaneously

Primary Outcome Measure Information:

Title

Daily Combined Score (DCS)

Description

Time Frame

Change from baseline at 10 weeks

Title

Mini RQLQ

Description

Time Frame

Change from baseline at 10 weeks

Secondary Outcome Measure Information:

Title

Rescue Medication Use

Description

Time Frame

Duration of intervention plus followup (12 weeks)

Title

Safety Assessment

Description

Safety and adverse events (AES) will be followed. We will measure and report systemic reactions.

Time Frame

continuous review of safety up to 14 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. The subject is a male or a non-pregnant, non-lactating female between the ages of 18 and 65. The subject is actively manifesting symptoms and signs of moderate to severe Perennial Allergic Rhinitis (PAR) with or without Seasonal Allergic Rhinitis (SAR) component defined as score of at least 28 on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and 6 on the Total Nasal Symptom Score (TNSS) scale. Scores will be determined on the first and second visit (after the 14 day medication washout period). Both scores exceeding their threshold on either day will qualify. Skin test strongly positive (wheal at least 5mm diameter and 2mm greater than negative control) to at least 6 of 48 allergy skin prick tests including at least one species of dust mite. Exclusion Criteria: The subject has received any investigational compound within 30 days prior to screening. The subject has received allergen immunotherapy or Sublingual immunotherapy (SLIT) in a previous clinical study or as a therapeutic agent within the past two years. The subject has a history or clinical manifestations of significant medical conditions (cardiovascular, hepatic, infectious or renal disease, etc.) which in the opinion of the investigator renders them unacceptable study subjects. The subject has a history of drug abuse (defined as any chronic illicit drug use) or a history of alcohol abuse within 5 years prior to the screening visit. The subject is required to take excluded medications listed in Section 6.3. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. Subjects found to have on physical exam significant nasal polyps, septal deviation or infectious sinusitis. The subject has a history of allergic rhinitis but is not currently manifesting active signs and symptoms of the disorder. Subject has a history of cancer, other than squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to Screening. (A history of treated Cervical Intraepithelial Neoplasia (CIN) I, II, or CIN III is allowed.)

Facility Information:

Facility Name

Johns Hopkins University School of Medicine

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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A Novel Biologic Therapy for Perennial Allergic Rhinitis

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