NCT00396409 is a Phase 3 clinical trial of Depigoid in Allergic Asthma, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT00396409?

NCT00396409 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT00396409?

Interventions in NCT00396409: Depigoid, Omalizumab, Placebo.

What condition does NCT00396409 study?

NCT00396409 studies Allergic Asthma.

Is NCT00396409 still recruiting?

NCT00396409 is currently completed. Last updated 28 February 2017.

Are results published for NCT00396409?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-02-28 · How we verify

NCT00396409

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, 20 Week, Double-blind, Placebo-controlled, Parallel-group, Multiple-dose, Multicenter Study to Assess the Efficacy and Safety of Omalizumab in Combination With Depigoid, Versus Depigoid Only, in Adult and Adolescent Patients With Seasonal Allergic Asthma and Comorbid Seasonal Allergic Rhinoconjunctivitis - Open-label Depigoid Monotherapy Extension Periods 2007 and 2008-

Completed Phase 3 Results posted Last updated 28 February 2017

What this trial tests

Phase 3 trial testing Depigoid in Allergic Asthma in 128 participants. Completed in 1 August 2008.

Timeline

1 February 2006

Primary endpoint
1 August 2008

1 August 2008

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	128
Start date	1 February 2006
Primary completion	1 August 2008
Estimated completion	1 August 2008
Sites	1 location across Germany

Drugs / interventions tested

Depigoid — full drug profile →
Omalizumab (omalizumab) — full drug profile →
Placebo

Conditions studied

Allergic Asthma — all drugs for Allergic Asthma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 12 to 45, any sex, with Allergic Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Daily Symptom Load
Time frame: Recorded daily during the 2007 and 2008 pollen season
The daily symptom load (low=0, high=unbounded) represents the daily combined asthma and rhinoconjunctivitis symptom severity scores plus the daily asthma rescue medication score based on patient diary entries. A higher score indicates a worse patient asthma condition. Symptoms (e.g. - difficulty breathing, cough, tightness of chest, sneezing, itchy nose, red eyes, etc.) were evaluated daily by the

Sponsor's own description

Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Allergic Asthma

Currently open trials in the same condition.

NCT07055542 — Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study · NA · recruiting
NCT06960382 — Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Ast · Phase 1, PHASE2 · recruiting
NCT07342803 — Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients · Phase 2 · recruiting
NCT06438757 — Trial of JYB1904 in Patients With Allergic Asthma · Phase 2 · active not recruiting
NCT06771934 — Combination Therapy of Omalizumab and Allergen Immunotherapy for Moderate to Severe Asthma · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00396409 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 28 February 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00396409.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing