NCT00396149

A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen

Completed Phase 1 Last updated 26 June 2013

What this trial tests

Phase 1 trial testing Placebo in Birch Pollen-Related Rhinoconjunctivitis in 57 participants. Completed in 1 June 2007.

Timeline

1 November 2006

Primary endpoint
1 March 2007

1 June 2007

Quick facts

Lead sponsor	Stallergenes Greer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	57
Start date	1 November 2006
Primary completion	1 March 2007
Estimated completion	1 June 2007
Sites	1 location across Denmark

Drugs / interventions tested

• Placebo
• rBet v 1 — full drug profile →

Conditions studied

• Birch Pollen-Related Rhinoconjunctivitis — all drugs for Birch Pollen-Related Rhinoconjunctivitis →
• Rhinitis, Allergic, Seasonal — all drugs for Rhinitis, Allergic, Seasonal →

Sponsor

Stallergenes Greer — full company profile →

Who can join

Adults 18 to 60, any sex, with Birch Pollen-Related Rhinoconjunctivitis or Rhinitis, Allergic, Seasonal. 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.

• Local tolerability
  Time frame: Assessed every day over 2 weeks
• Global safety
  Time frame: Assessed every day over 2 weeks

Sponsor's own description

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Allergen Extracts for In Vivo Diagnosis and Treatment of Allergy: Is There a Future?
   Valenta R, Karaulov A, Niederberger V, Zhernov Y, et al · · 2018 · cited 82× · PMID 30297269 · DOI 10.1016/j.jaip.2018.08.032
2. Next-Generation of Allergen-Specific Immunotherapies: Molecular Approaches.
   Curin M, Khaitov M, Karaulov A, Namazova-Baranova L, et al · · 2018 · cited 46× · PMID 29886521 · DOI 10.1007/s11882-018-0790-x
3. Recombinant allergens for immunotherapy: state of the art.
   Zhernov Y, Curin M, Khaitov M, Karaulov A, et al · · 2019 · cited 45× · PMID 31082821 · DOI 10.1097/aci.0000000000000536
4. Single recombinant and purified major allergens and peptides: How they are made and how they change allergy diagnosis and treatment.
   Curin M, Garib V, Valenta R. · · 2017 · cited 39× · PMID 28890016 · DOI 10.1016/j.anai.2016.11.022
5. Recombinant allergens: the present and the future.
   Jutel M, Solarewicz-Madejek K, Smolinska S. · · 2012 · cited 20× · PMID 23095874 · DOI 10.4161/hv.22064
6. [Recombinant allergens, peptides, and virus-like particles for allergy immunotherapy].
   Holzhauser T, Schuler F, Dudek S, Kaul S, et al · · 2020 · cited 2× · PMID 33095280 · DOI 10.1007/s00103-020-03231-7