A Novel Biologic Therapy for Perennial Allergic Rhinitis

NCT03360071 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00107909
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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).

  Change from baseline at 10 weeks

• 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).

  Change from baseline at 10 weeks

Secondary Outcomes (2)

• Rescue Medication Use

  Duration of intervention plus followup (12 weeks)

• Safety Assessment

  continuous review of safety up to 14 week

Study Arms (2)

Allergen Immunotherapy Group

EXPERIMENTAL

Drug: Allergen Immunotherapy Extract

Control Group

PLACEBO COMPARATOR

Drug: Allergen Immunotherapy Control

Interventions

Allergen Immunotherapy Extract DRUG

Allergen Immunotherapy treatment mixture to be delivered subcutaneously

Allergen Immunotherapy Group

Allergen Immunotherapy Control DRUG

Allergen Immunotherapy Control Solution to be delivered subcutaneously

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Desensitization, Immunologic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Jody Tversky, MD
• Organization: John Hopkins University School of Medicine

hoddin1@jhmi.edu

410-550-2300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 2, 2017
• Study Start: December 19, 2016
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)