Trial Outcomes & Findings for Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy (NCT NCT01720251)
NCT ID: NCT01720251
Last Updated: 2015-04-13
Results Overview
The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2
COMPLETED
PHASE2
240 participants
up to 6 weeks during the birch pollen season 2013
2015-04-13
Participant Flow
Participant milestones
| Measure |
Placebo
SC injections of placebo
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56
|
AllerT Low Dose
SC injections of AllerT 25 or 50 micrograms
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
|
AllerT Full Dose
SC injections of AllerT 50-100 micrograms
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
79
|
82
|
|
Overall Study
COMPLETED
|
78
|
77
|
82
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy
Baseline characteristics by cohort
| Measure |
Placebo
n=79 Participants
SC injections of placebo
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56
|
AllerT Low Dose
n=78 Participants
SC injections of AllerT 25 or 50 micrograms
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
|
AllerT Full Dose
n=82 Participants
SC injections of AllerT 50-100 micrograms
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 9.08 • n=99 Participants
|
36.2 years
STANDARD_DEVIATION 9.92 • n=107 Participants
|
36.4 years
STANDARD_DEVIATION 9.36 • n=206 Participants
|
35.6 years
STANDARD_DEVIATION 9.45 • n=7 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
124 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 6 weeks during the birch pollen season 2013The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2
Outcome measures
| Measure |
Placebo
n=78 Participants
SC injections of placebo
placebo: SC injections of placebo on days 1, 7, 14, 28 and 56
|
AllerT Low Dose
n=77 Participants
SC injections of AllerT 25 or 50 micrograms
AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
|
AllerT Full Dose
n=82 Participants
SC injections of AllerT 50-100 micrograms
AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
|
|---|---|---|---|
|
Combined Rhinoconjunctivitis Symptom and Medication Score
|
0.86 score (maximum=3)
Standard Deviation 0.603
|
0.64 score (maximum=3)
Standard Deviation 0.530
|
0.72 score (maximum=3)
Standard Deviation 0.573
|
SECONDARY outcome
Timeframe: up to 6 weeks during the birch pollen season 2013mini-RQLQ questionnaires
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeksAdverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Allert 50 µg
AllerT 100 µg
Serious adverse events
| Measure |
Placebo
n=79 participants at risk
All patients having received at least one injection of Placebo (Safety Set)
|
Allert 50 µg
n=78 participants at risk
All patients having received at least one injection of Allert 50 µg (Safety Set)
|
AllerT 100 µg
n=82 participants at risk
All patients having received at least one injection of Allert 100 µg (Safety Set)
|
|---|---|---|---|
|
Eye disorders
conjunctivitis
|
0.00%
0/79
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
General disorders
Hypersensitivity
|
0.00%
0/79
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
Oropharyngeal discomfort
|
0.00%
0/79
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Musculoskeletal and connective tissue disorders
Skull fracture
|
0.00%
0/79
|
0.00%
0/78
|
1.2%
1/82 • Number of events 1
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/79
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/79
|
1.3%
1/78 • Number of events 1
|
0.00%
0/82
|
Other adverse events
| Measure |
Placebo
n=79 participants at risk
All patients having received at least one injection of Placebo (Safety Set)
|
Allert 50 µg
n=78 participants at risk
All patients having received at least one injection of Allert 50 µg (Safety Set)
|
AllerT 100 µg
n=82 participants at risk
All patients having received at least one injection of Allert 100 µg (Safety Set)
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site pain
|
32.9%
26/79
|
25.6%
20/78
|
19.5%
16/82
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
12.7%
10/79
|
24.4%
19/78
|
18.3%
15/82
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
17.7%
14/79
|
16.7%
13/78
|
19.5%
16/82
|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
22.8%
18/79
|
9.0%
7/78
|
13.4%
11/82
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
8.9%
7/79
|
28.2%
22/78
|
30.5%
25/82
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.3%
5/79
|
21.8%
17/78
|
30.5%
25/82
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
2/79
|
15.4%
12/78
|
31.7%
26/82
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
3/79
|
25.6%
20/78
|
13.4%
11/82
|
|
Eye disorders
Conjunctivitis
|
6.3%
5/79
|
14.1%
11/78
|
14.6%
12/82
|
|
Skin and subcutaneous tissue disorders
Injection site oedema
|
11.4%
9/79
|
10.3%
8/78
|
15.9%
13/82
|
Additional Information
Dr Gilles DELLA CORTE Clinical Development Director
ANERGIS SA
Results disclosure agreements
- Principal investigator is a sponsor employee The PI of the trial owns options in the sponsor company and is member of the Board of Anergis SA
- Publication restrictions are in place
Restriction type: OTHER