Trial Outcomes & Findings for Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment (NCT NCT02143583)

Results Overview

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 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3). The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows: 0 = no medication 1. = subject took topical antihistamine 2. = subject took oral antihistamine 3. = subject took oral corticosteroids

Recruitment status

COMPLETED

Target enrollment

196 participants

Primary outcome timeframe

from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3

Results posted on

2015-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	AllerT 100 μg patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T	AllerT 50 μg patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T	Placebo Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
Overall Study STARTED	62	66	68
Overall Study COMPLETED	61	66	66
Overall Study NOT COMPLETED	1	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AllerT 100 μg patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T	AllerT 50 μg patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T	Placebo Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
Overall Study Withdrawal by Subject	1	0	1
Overall Study husband illness	0	0	1

Baseline Characteristics

Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AllerT 100 μg n=62 Participants patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T	AllerT 50 μg n=66 Participants patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T	Placebo n=68 Participants Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T	Total n=196 Participants Total of all reporting groups
Age, Continuous	39.0 years STANDARD_DEVIATION 9.0 • n=5 Participants	37.9 years STANDARD_DEVIATION 9.4 • n=7 Participants	35.5 years STANDARD_DEVIATION 9.3 • n=5 Participants	37.4 years STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	37 Participants n=7 Participants	34 Participants n=5 Participants	101 Participants n=4 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	29 Participants n=7 Participants	34 Participants n=5 Participants	95 Participants n=4 Participants

PRIMARY outcome

Timeframe: from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3

Population: Modified-ITT analysis set : participants having received at least 4 injections of AllerT or placebo in AN004T

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 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3). The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows: 0 = no medication 1. = subject took topical antihistamine 2. = subject took oral antihistamine 3. = subject took oral corticosteroids

Outcome measures

Outcome measures
Measure	AllerT 100 μg n=57 Participants patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T	AllerT 50 μg n=64 Participants patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T	Placebo n=68 Participants Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season	0.853 units on a scale Standard Deviation 0.524	0.795 units on a scale Standard Deviation 0.421	0.959 units on a scale Standard Deviation 0.487

SECONDARY outcome

Timeframe: between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3

Population: Modified-ITT analysis set : patients having received at least 4 injections of AllerT or placebo in AN004T

The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms). For each question the answer is quoted from 0: "no troubled" to 6: "extremely troubled"; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case

Outcome measures

Outcome measures
Measure	AllerT 100 μg n=57 Participants patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T	AllerT 50 μg n=64 Participants patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T	Placebo n=68 Participants Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season	1.486 units on a scale Standard Deviation 1.017	1.479 units on a scale Standard Deviation 0.879	1.767 units on a scale Standard Deviation 1.054

Adverse Events

AllerT 100 μg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

AllerT 50 μg

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AllerT 100 μg n=62 participants at risk patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T	AllerT 50 μg n=66 participants at risk patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T	Placebo n=68 participants at risk Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/62	1.5% 1/66 • Number of events 1	0.00% 0/68
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/62	1.5% 1/66 • Number of events 1	0.00% 0/68
Pregnancy, puerperium and perinatal conditions Threatened labor	0.00% 0/62	1.5% 1/66 • Number of events 1	0.00% 0/68

Other adverse events

Other adverse events
Measure	AllerT 100 μg n=62 participants at risk patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T	AllerT 50 μg n=66 participants at risk patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T	Placebo n=68 participants at risk Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	3.2% 2/62 • Number of events 2	1.5% 1/66 • Number of events 1	5.9% 4/68 • Number of events 4

Additional Information

G. DELLA CORTE Clinical Development Director

ANERGIS SA

Phone: +41 21 651 92 30

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI coordinator of the study owns shares in Anergis SA
Publication restrictions are in place

Restriction type: OTHER