Trial Outcomes & Findings for An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy (NCT NCT01454531)

Results Overview

Frequency of patients with adverse reactions, local or systemic

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

199 participants

Primary outcome timeframe

6 weeks

Results posted on

2015-03-06

Participant Flow

199 subjects were recruited and 3 resulted screening failures so 196 subjects started the trial. Four subjects discontinued before treatment so 192 subjects were treated. The reason for discontinuation for these 4 subjects was withdrawal of consent ("Withdrawal by subject", included in Reasons Not Completed)

Participant milestones

Participant milestones
Measure	AVANZ Phleum Pratense AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Overall Study STARTED	196
Overall Study Subjects Treated	192
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	AVANZ Phleum Pratense AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Overall Study Adverse Event	14
Overall Study Withdrawal by Subject	5
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	1
Overall Study Delay in IMP administration	1
Overall Study Other	1

Baseline Characteristics

An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AVANZ Phleum Pratense n=192 Participants AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Age, Continuous	32.8 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Region of Enrollment Spain	192 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Subjects treated

Frequency of patients with adverse reactions, local or systemic

Outcome measures

Outcome measures
Measure	AVANZ Phleum Pratense n=192 Participants AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Frequency of Subjects With Adverse Drug Reactions	133 participants

SECONDARY outcome

Timeframe: 6 weeks

Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)

Outcome measures

Outcome measures
Measure	AVANZ Phleum Pratense n=192 Participants AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Frequency of Subjects With Systemic Reactions	66 participants

SECONDARY outcome

Timeframe: 6 weeks

Frequency of patients with local adverse reactions

Outcome measures

Outcome measures
Measure	AVANZ Phleum Pratense n=192 Participants AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Frequency of Subjects With Local Adverse Reaction	109 participants

SECONDARY outcome

Timeframe: baseline (visit 1) and at 6 weeks (visit 6)

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

Outcome measures

Outcome measures
Measure	AVANZ Phleum Pratense n=167 Participants AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Change in Phleum Pratense Specific IgE-blocking Factor Visit 1	-0.13 arbitrary units Standard Deviation 0.2
Change in Phleum Pratense Specific IgE-blocking Factor Visit 6	0.12 arbitrary units Standard Deviation 0.3

SECONDARY outcome

Timeframe: baseline (visit 1) and at 6 weeks (visit 6)

Population: Number of subject with valid data in visit 1 and visit 6

Outcome measures

Outcome measures
Measure	AVANZ Phleum Pratense n=171 Participants AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Change in Phleum Pratense Specific IgG4 Visit 1	0.44 mgA/l Standard Deviation 0.6
Change in Phleum Pratense Specific IgG4 Visit 6	2.26 mgA/l Standard Deviation 2.5

SECONDARY outcome

Timeframe: baseline (visit 1) and at 6 weeks (visit 6)

Population: Participants in which results of the Parallel Line Assay are valid

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

Outcome measures

Outcome measures
Measure	AVANZ Phleum Pratense n=129 Participants AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Change in Immediate Cutaneous Response to Phleum Pratense	1.79 CTI, Cutaneous Tolerance Index Interval 1.49 to 2.16

Adverse Events

AVANZ Phleum Pratense

Serious events: 3 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AVANZ Phleum Pratense n=192 participants at risk AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Skin and subcutaneous tissue disorders Generalised urticaria	0.52% 1/192 • Number of events 1 • 6 weeks
Immune system disorders Anaphylactic reaction	1.0% 2/192 • Number of events 2 • 6 weeks

Other adverse events

Other adverse events
Measure	AVANZ Phleum Pratense n=192 participants at risk AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense
Immune system disorders Hypersensitivity	5.2% 10/192 • Number of events 14 • 6 weeks
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	7.8% 15/192 • Number of events 19 • 6 weeks
Skin and subcutaneous tissue disorders Urticaria	8.9% 17/192 • Number of events 17 • 6 weeks
General disorders Local reactions	56.8% 109/192 • Number of events 262 • 6 weeks

Additional Information

ALICIA MARIN

ALK-ABELLÓ

Phone: +34 913276127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All presentations/publications must be approved by ALK prior to public presentation/submission. Investigators agree not to present data gathered from one trial centre or a small group of trial centres before the full publication unless formally agreed by all other investigators and ALK. ALK has the right to review and comment any manuscript within 30 days of receipt, but cannot prevent publications of findings.
Publication restrictions are in place

Restriction type: OTHER