Phase III Cat-PAD Study

NCT01620762 | Completed Phase 3 Results DMC

• 1 other identifier: CP007
• Study Type: interventional
• Target: 1,408
• Locations: 9 countries
• Sites: 118

Brief Summary

The purpose of this study is to compare the treatment effect of two treatment regimens of Cat-PAD vs placebo and to evaluates the treatment effect of Cat-PAD on symptoms, rescue medication usage and Quality of Life.

Conditions

Rhinoconjunctivitis

Keywords

Cat allergy; Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo

  The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of 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 ocular 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) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3. RMS was scored 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.

  52-54 weeks after randomisation

Secondary Outcomes (6)

• Mean TRSS

  52-54 weeks after randomisation

• Mean Daily TNSS in Cat-PAD Compared With Placebo

  52-54 weeks after randomisation

• Mean Daily TOSS in Cat-PAD Compared to Placebo

  52-54 weeks after randomisation

• Mean RMS in Cat-PAD Compared With Placebo

  52-54 weeks after randomisation

• Mean RQLQ Score in Cat-PAD Compared With Placebo

  52-54 weeks after randomisation

Study Arms (3)

Cat-Pad Treatment 1

EXPERIMENTAL

Cat-PAD Treatment 1

Drug: Cat-PAD

Cat-PAD Treatment 2

EXPERIMENTAL

Cat-PAD Treatment regimen 2

Drug: Cat-PAD; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Cat-PAD DRUG

1 dose every 4 weeks

Cat-PAD Treatment 2; Cat-Pad Treatment 1

Placebo DRUG

1 dose every 4 weeks

Cat-PAD Treatment 2; Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 12-65 years.
• Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years.
• Subjects may optionally also have GINA Step 1 controlled asthma.
• Positive skin prick test to cat hair.
• Cat dander specific IgE ≥0.35 kU/L.

You may not qualify if:

• Asthma falling under the GINA definitions "partly controlled" and "uncontrolled" or Steps 2 to 5.
• FEV1 \<80% of predicted.
• Clinically significant confounding symptoms of allergy to seasonal allergens during the final evaluation period.
• Skin prick test 5 mm greater than the negative control to perennial allergens or animal dander (other than cat) which cannot be avoided during the study.
• 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
• inVentiv Health Clinical: collaborator
• Pharm-Olam International: collaborator

Study Sites (118)

Unknown Facility

Rolling Hills Estates, California, United States

Location

Unknown Facility

Colorado Springs, Colorado, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Wheat Ridge, Colorado, United States

Location

Unknown Facility

Eagle, Idaho, United States

Location

Unknown Facility

Meridian, Idaho, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Forrest, Illinois, United States

Location

Unknown Facility

Normal, Illinois, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Bangor, Maine, United States

Location

Unknown Facility

Brockton, Massachusetts, United States

Location

Unknown Facility

Ypsilanti, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Bozeman, Montana, United States

Location

Unknown Facility

Missoula, Montana, United States

Location

Unknown Facility

Bellevue, Nebraska, United States

Location

Unknown Facility

Fremont, Nebraska, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Ocean Township, New Jersey, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Corning, New York, United States

Location

Unknown Facility

Newburgh, New York, United States

Location

Unknown Facility

Fargo, North Dakota, United States

Location

Unknown Facility

Minot, North Dakota, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Middleburg Heights, Ohio, United States

Location

Unknown Facility

Sylvania, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Tulsa, Oklahoma, United States

Location

Unknown Facility

Lake Oswego, Oregon, United States

Location

Unknown Facility

Medford, Oregon, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Blue Bell, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Draper, Utah, United States

Location

Unknown Facility

Glen Allen, Virginia, United States

Location

Unknown Facility

South Burlington, Virginia, United States

Location

Unknown Facility

Warrenton, Virginia, United States

Location

Unknown Facility

Spokane, 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

Brussels, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Burlington, Ontario, Canada

Location

Unknown Facility

Corruna, Ontario, Canada

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

Kanata, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Newmarket, Ontario, Canada

Location

Unknown Facility

Niagara Falls, Ontario, Canada

Location

Unknown Facility

Oshawa, Ontario, Canada

Location

Unknown Facility

Ottawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Pointe-Claire, Quebec, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Unknown Facility

Trois-Rivières, Quebec, Canada

Location

Unknown Facility

Brnho, Czechia

Location

Unknown Facility

Čáslav, Czechia

Location

Unknown Facility

České Budějovice, Czechia

Location

Unknown Facility

Jablonec nad Nisou, Czechia

Location

Unknown Facility

Kutná Hora, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Rychnov nad Kněžnou, Czechia

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Bramsche, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Mönchengladbach, Germany

Location

Unknown Facility

München, Germany

Location

Unknown Facility

Münster, Germany

Location

Unknown Facility

Neuss, Germany

Location

Unknown Facility

Osnabrück, Germany

Location

Unknown Facility

Wesel, Germany

Location

Unknown Facility

Wiesbaden, Germany

Location

Unknown Facility

Wuppertal, Germany

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Csorna, Hungary

Location

Unknown Facility

Pécs, Hungary

Location

Unknown Facility

Tatabánya, Hungary

Location

Unknown Facility

Bydgoszcz, Poland

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Rzeszów, Poland

Location

Unknown Facility

Tarnów, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Zabrze, Poland

Location

Unknown Facility

Zawadzkie, Poland

Location

Unknown Facility

Barnaul, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Novosibirsk, Russia

Location

Unknown Facility

Omsk, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Stavropol, Russia

Location

Unknown Facility

Tomsk, Russia

Location

Unknown Facility

Yekaterinburg, Russia

Location

Unknown Facility

Bardejov, Slovakia

Location

Unknown Facility

Martin, Slovakia

Location

Unknown Facility

Poprad, Slovakia

Location

Results Point of Contact

• Title: VP Clinical Operations
• Organization: Circassia Ltd

+44 1865 405560

Study Officials

• Harold Nelson, MD

  Jewish National Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 30, 2012
• First Posted: June 15, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Last Updated: June 15, 2018
• Results First Posted: May 14, 2018

Record last verified: 2018-05

Locations

US (52); BE (3); DE (14); SL (3); HU (4); PL (13); CA (14); CZ (7); RU (8)