A Phase 2/3 interventional study of AVANZ Phleum pratense in Allergic Rhinoconjunctivitis, sponsored by ALK-Abelló A/S. Completed at 20 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by ALK-Abelló A/S · Phase 2/3, Interventional, and Treatment
The purpose of this study is to assess the tolerability of AVANZ.
To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.
ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
Drug: AVANZ Phleum pratense
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
Frequency of Subjects With Adverse Drug Reactions
Frequency of patients with adverse reactions, local or systemic
Time frame: 6 weeks
Frequency of Subjects With Systemic Reactions
Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)
Time frame: 6 weeks
Frequency of Subjects With Local Adverse Reaction
Frequency of patients with local adverse reactions
Time frame: 6 weeks
Change in Phleum Pratense Specific IgE-blocking Factor
IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of: IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure
Time frame: baseline (visit 1) and at 6 weeks (visit 6)
Change in Phleum Pratense Specific IgG4
Time frame: baseline (visit 1) and at 6 weeks (visit 6)
Change in Immediate Cutaneous Response to Phleum Pratense
Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1
Time frame: baseline (visit 1) and at 6 weeks (visit 6)
| Milestone | AVANZ Phleum Pratense |
|---|---|
| Started | 196 |
| Subjects treated | 192 |
| Completed | 173 |
| Not completed | 23 |
| Withdrew: Adverse event | 14 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Delay in imp administration | 1 |
| Withdrew: Other | 1 |
Frequency of patients with adverse reactions, local or systemic
| participants | AVANZ Phleum Pratense |
|---|---|
| Frequency of Subjects With Adverse Drug Reactions | 133 |
Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)
| participants | AVANZ Phleum Pratense |
|---|---|
| Frequency of Subjects With Systemic Reactions | 66 |
Frequency of patients with local adverse reactions
| participants | AVANZ Phleum Pratense |
|---|---|
| Frequency of Subjects With Local Adverse Reaction | 109 |
IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of: IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure
| arbitrary units | AVANZ Phleum Pratense |
|---|---|
| Visit 1 | -0.13 ± 0.2 |
| Visit 6 | 0.12 ± 0.3 |
| mgA/l | AVANZ Phleum Pratense |
|---|---|
| Visit 1 | 0.44 ± 0.6 |
| Visit 6 | 2.26 ± 2.5 |
Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1
| CTI, Cutaneous Tolerance Index | AVANZ Phleum Pratense |
|---|---|
| Change in Immediate Cutaneous Response to Phleum Pratense | 1.79 (1.49 to 2.16) |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AVANZ Phleum Pratense | — | 3/192 (1.6%) | 109/192 (56.8%) |
| Event | AVANZ Phleum Pratense |
|---|---|
| Anaphylactic reactionImmune system disorders | 2/192 |
| Generalised urticariaSkin and subcutaneous tissue disorders | 1/192 |
| Event | AVANZ Phleum Pratense |
|---|---|
| Local reactionsGeneral disorders | 109/192 |
| UrticariaSkin and subcutaneous tissue disorders | 17/192 |
| Rhinitis allergicRespiratory, thoracic and mediastinal disorders | 15/192 |
| HypersensitivityImmune system disorders | 10/192 |
Subjects treated
| Age, Continuous(years) | AVANZ Phleum Pratense |
|---|---|
| Mean | 32.8 ± 9.4 |
| Sex: Female, Male(Participants) | AVANZ Phleum Pratense |
|---|---|
| Female | 98 |
| Male | 94 |
| Region of Enrollment(participants) | AVANZ Phleum Pratense |
|---|---|
| Spain | 192 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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ALK-Abelló A/S