Phase II HDM-SPIRE Safety and Efficacy Study

NCT02150343 | Completed Phase 2 Results DMC

• 1 other identifier: TH005
• Study Type: interventional
• Target: 715
• Locations: 8 countries
• Sites: 98

Brief Summary

The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

Conditions

Rhinoconjunctivitis

Keywords

Cat allergy; Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Combined Score of Symptoms and Allergy Medication

  The primary endpoint was mean Combined Score (CS) over a 3 week period (50-52 weeks after randomisation) in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. A higher score indicated more severe symptoms or greater use of allergy rescue medication and thus a low score indicated a better outcome. CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing, blocked nose and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe); TRSS was divided by the number of symptoms (8) to provide an average score per symptom of 0-3. The RMS score ranged from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6.

  Weeks 50 to 52 after randomisation

Secondary Outcomes (7)

• Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo

  Weeks 50 to 52 after randomisation

• Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline

  Weeks 50 to 52 after randomisation

• Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo

  Weeks 50 to 52 after randomisation

• Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo

  Weeks 50 to 52 after randomisation

• Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo

  Weeks 50 to 52 after randomisation

Study Arms (4)

HMD-SPIRE Treatment 1

EXPERIMENTAL

4 x 12 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart

Drug: HDM-SPIRE; Drug: Placebo

HDM-SPIRE Treatment 2

EXPERIMENTAL

4 x 12 nmol HDM-SPIRE 4 weeks apart followed by a second course of 4 x 12 nmol HDM-SPIRE 4 weeks apart

Drug: HDM-SPIRE

HDM-SPIRE Treatment 3

EXPERIMENTAL

4 x 20 nmol HDM-SPIRE followed by 4 x placebo 4 weeks apart

Drug: HDM-SPIRE; Drug: Placebo

Placebo

PLACEBO COMPARATOR

8 x placebo 4 weeks apart

Drug: Placebo

Interventions

HDM-SPIRE DRUG

1 dose every 4 weeks

HDM-SPIRE Treatment 2; HDM-SPIRE Treatment 3; HMD-SPIRE Treatment 1

Placebo DRUG

1 dose every 4 weeks

HDM-SPIRE Treatment 3; HMD-SPIRE Treatment 1; Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female, aged 18-65 years.
• Moderate to severe rhinoconjunctivitis on exposure to HDM for at least 1 years.
• Mean TRSS ≥10
• Positive skin prick test to Der p and Der f.
• Dep p and Der f specific IgE ≥0.7 kU/L

You may not qualify if:

• Diagnosis of asthma requiring Global Initiative for Asthma (GINA) Step 3 (www.ginasthma.org)or higher treatment
• FEV1 \<80% of predicted.
• Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
• Significant symptoms of another clinically relevant illness that is likely to affect scoring of rhinoconjunctivitis symptoms.
• Clinically relevant abnormalities detected on physical examination.
• History of severe drug allergy, severe angioedema or anaphylactic reaction to food.

Sponsors & Collaborators

• Circassia Limited: lead
• Quintiles, Inc.: collaborator

Study Sites (98)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Huntington Beach, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Mission Viejo, California, United States

Location

Unknown Facility

Napa, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

Redwood City, California, United States

Location

Unknown Facility

Rolling Hills Estates, California, United States

Location

Unknown Facility

Roseville, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Walnut Creek, California, United States

Location

Unknown Facility

Waterbury, Connecticut, United States

Location

Unknown Facility

Tallahassee, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Stockbridge, Georgia, United States

Location

Unknown Facility

Normal, Illinois, United States

Location

Unknown Facility

Shiloh, Illinois, United States

Location

Unknown Facility

Evansville, Indiana, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Owensboro, Kentucky, United States

Location

Unknown Facility

Bangor, Maine, United States

Location

Unknown Facility

Bethesda, Maryland, United States

Location

Unknown Facility

Gaithersburg, Maryland, United States

Location

Unknown Facility

Brockton, Massachusetts, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Plymouth, Minnesota, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Bellevue, Nebraska, United States

Location

Unknown Facility

Ocean City, New Jersey, United States

Location

Unknown Facility

Teaneck, New Jersey, United States

Location

Unknown Facility

Verona, New Jersey, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Rockville Centre, New York, United States

Location

Unknown Facility

Asheville, North Carolina, United States

Location

Unknown Facility

High Point, North Carolina, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Tulsa, Oklahoma, United States

Location

Unknown Facility

Medford, Oregon, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Bethlehem, Pennsylvania, United States

Location

Unknown Facility

Blue Bell, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Kerrville, Texas, United States

Location

Unknown Facility

Plano, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

South Burlington, Vermont, United States

Location

Unknown Facility

Henrico, Virginia, United States

Location

Unknown Facility

Bellingham, Washington, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Vancouver, Washington, United States

Location

Unknown Facility

Greenfield, Wisconsin, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Niagara, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Unknown Facility

Saint Romuald, Quebec, Canada

Location

Unknown Facility

Trois-Rivières, Quebec, Canada

Location

Unknown Facility

Reims, Marne, France

Location

Unknown Facility

Gironde, Pessac, France

Location

Unknown Facility

Bas Rhin, Strasbourg, France

Location

Unknown Facility

Meurthe-et-Moselle, Vandoeuvre Les Nancy, France

Location

Unknown Facility

Heidelberg, Baden-Wurttemberg, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Goch, North Rhine-Westphalia, Germany

Location

Unknown Facility

Dresden, Saxony, Germany

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Ancona, Torrette Di Ancona, Italy

Location

Unknown Facility

Genova, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Parma, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Roma, Italy

Location

Unknown Facility

Siena, Italy

Location

Unknown Facility

Almere Stad, Netherlands

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Beek, Netherlands

Location

Unknown Facility

Durban, KwaZulu-Natal, South Africa

Location

Unknown Facility

eMkhomazi, KwaZulu-Natal, South Africa

Location

Unknown Facility

Ottawa, KwaZulu-Natal, South Africa

Location

Unknown Facility

Cape Town, Western Cape, South Africa

Location

Unknown Facility

Sabadell, Barcelona, Spain

Location

Unknown Facility

Santander, Cantabria, Spain

Location

Unknown Facility

Girona, Catalonia, Spain

Location

Unknown Facility

Donostia / San Sebastian, Guipuzcoa, Spain

Location

Unknown Facility

Pamplona, Navarre, Spain

Location

Unknown Facility

Bilbao, Vizcaya, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Seville, Spain

Location

Results Point of Contact

• Title: VP Clinical Operations
• Organization: Circassia Ltd

kirsten.evans@circassia.com

+44 1865 405560

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 29, 2014
• Study Start: September 1, 2014
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: June 15, 2018
• Results First Posted: June 15, 2018

Record last verified: 2018-05

Locations

ZA (4); ES (8); FR (4); US (56); NL (3); CA (10); DE (6); IT (7)