Who is sponsoring NCT01567306?

NCT01567306 is sponsored by Roxall Medicina España S.A.

What drugs are being tested in NCT01567306?

Interventions in NCT01567306: Allergovac Depot, Allergovac Depot, Allergovac Depot, Allergovac Depot, Allergovac Depot, Placebo.

What condition does NCT01567306 study?

NCT01567306 studies Allergic Rhinoconjunctivitis.

Is NCT01567306 still recruiting?

NCT01567306 is currently completed. Last updated 28 January 2019.

Are results published for NCT01567306?

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

Last reviewed 2019-01-28 · How we verify

NCT01567306

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

Phase II, Multicenter, Randomized, Double Blind Study, With Subcutaneous Immunotherapy At Different Doses, in Parallel Groups and Placebo-Controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Phleum Pratense

Completed Phase 2 Results posted Last updated 28 January 2019

What this trial tests

Phase 2 trial testing Allergovac Depot in Allergic Rhinoconjunctivitis in 151 participants. Completed in 1 April 2013.

Timeline

1 October 2011

Primary endpoint
1 April 2013

1 April 2013

Quick facts

Lead sponsor	Roxall Medicina España S.A
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	151
Start date	1 October 2011
Primary completion	1 April 2013
Estimated completion	1 April 2013
Sites	10 locations across Portugal, Spain

Drugs / interventions tested

Allergovac Depot — full drug profile →
Allergovac Depot — full drug profile →
Allergovac Depot — full drug profile →
Allergovac Depot — full drug profile →
Allergovac Depot — full drug profile →
Placebo

Conditions studied

Allergic Rhinoconjunctivitis — all drugs for Allergic Rhinoconjunctivitis →

Sponsor

Roxall Medicina España S.A — full company profile →

Who can join

Adults 18 to 60, any sex, with Allergic Rhinoconjunctivitis. 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.

Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).
Time frame: Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.
Variation of the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).

Sponsor's own description

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.

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 Rhinoconjunctivitis

Currently open trials in the same condition.

NCT06778213 — Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomi · Phase 4 · recruiting

Other Roxall Medicina España S.A trials

Trials by the same sponsor.

NCT03821077 — Study to Evaluate the Efficacy and Safety of "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhi · completed
NCT02844842 — Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhin · completed

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 NCT01567306 (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 Roxall Medicina España S.A
Last refreshed: 28 January 2019

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/NCT01567306.

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