Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy

• Sponsor: Anergis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01720251
• Collaborator: (none)
• Enrollment: 240
• Locations: 24
• Arms: 3
• Duration (Months): 11
• Patients Per Site: 10
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis; Rhinoconjunctivitis	Drug: placebo; Drug: AllerT low dose; Drug: AllerT full dose	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo SC injections of placebo	Drug: placebo; SC injections of placebo on days 1, 7, 14, 28 and 56
Experimental: AllerT low dose SC injections of AllerT 25 or 50 micrograms	Drug: AllerT low dose; SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56; Other Names: AllerT 25-50 micrograms
Experimental: AllerT full dose SC injections of AllerT 50-100 micrograms	Drug: AllerT full dose; SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56; Other Names: AllerT 50-100 micrograms

Outcome Measures

Primary Outcome Measures

1. Combined Rhinoconjunctivitis Symptom and Medication Score [up to 6 weeks during the birch pollen season 2013]

   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

Secondary Outcome Measures

1. Quality of Life [up to 6 weeks during the birch pollen season 2013]

   mini-RQLQ questionnaires

2. Safety and Tolerability [from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks]

   Adverse 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

Other Outcome Measures

1. Immunological Markers: Specific IgE and IgG4 [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 2013]

   blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• moderate to severe allergic rhinoconjunctivitis to birch pollen:

1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons

2. Previous use of anti-allergy medications during the two preceding birch pollen seasons

3. Positive SPT to birch pollen extract

4. Positive specific IgE CAP test for Bet v 1

Exclusion Criteria:

• uncontrolled asthma, FEV1 < 80% of predicted

• previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years

• clinical symptoms due to allergens other than birch pollen during the whole trial period

• history of anaphylaxis

• positive skin prick test to AllerT

• any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergiklinikken	Hellerup	Copenhagen	Denmark	2900
2	Lungemedicinsk Forskningsafdeling	Arhus		Denmark	8000
3	Klinisk Institute	Odense		Denmark	5000
4	CHU de Reims	Reims		France	51092
5	Hopitaux Universitaires de Strasbourg	Strasbourg		France	67000
6	Viktorija Vevere private practice of Allergology	Rezekne		Latvia	4601
7	Paul Stradins Clinical University Hospital - Pulmonology Allergology	Riga		Latvia	1002
8	Center of examination and treatment of allergic diseases	Riga		Latvia	1003
9	Kaunas Clinics University Hospital	Kaunas		Lithuania	50009
10	Allergy Clinic JSC Perspektyvos	Vilnius		Lithuania	08431
11	Vilnius University Hospital	Vilnius		Lithuania	08661
12	Antakalnio affiliation of the Vilnius City Allergy Center	Vilnius		Lithuania	10200
13	SPZOZ Uniwersytecki Szpital Kliniczny - Allergology	Lodz		Poland	90153
14	Alergologii Centrum	Lodz		Poland	90553
15	Alergotest	Lublin		Poland	20095
16	Alergo-Med	Tarnow		Poland	33100
17	Centrum Alergologii IRMED	Warszawa		Poland	01157
18	Silesian Piasts University of Medicine in Wrocław	Wroclaw		Poland	50-368
19	Aler-med	Wroclaw		Poland	54203
20	NZOZ Przychodnia Lekarska Hipokrates	Zabrze		Poland	41800
21	University hospital Skane	Lund		Sweden	22185
22	Orebro University Hospital	Orebro		Sweden	70185
23	Lungavdelningen, Vastmanlands	Vasteras		Sweden	72189
24	Centre Hospitalier Universitaire Vaudois	Lausanne	VD	Switzerland	1005

Sponsors and Collaborators

• Anergis

Investigators

• Principal Investigator: Francois Spertini, MD, Centre Hospitalier Universitaire Vaudois

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anergis
• ClinicalTrials.gov Identifier: NCT01720251
• Other Study ID Numbers: AN004T; 2011-002259-32
• First Posted: Nov 2, 2012
• Last Update Posted: Apr 13, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Anergis: allergic rhinitis; birch pollen; immunotherapy
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic

Study Results

Participant Flow

Arm/Group Title	Placebo	AllerT Low Dose	AllerT Full Dose
Arm/Group Description	SC injections of placebo placebo: SC injections of placebo on days 1, 7, 14, 28 and 56	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	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
Period Title: Overall Study
STARTED	79	79	82
COMPLETED	78	77	82
NOT COMPLETED	1	2	0

Baseline Characteristics

Arm/Group Title	Placebo	AllerT Low Dose	AllerT Full Dose	Total
Arm/Group Description	SC injections of placebo placebo: SC injections of placebo on days 1, 7, 14, 28 and 56	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	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 of all reporting groups
Overall Participants	79	78	82	239
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.1 (9.08)	36.2 (9.92)	36.4 (9.36)	35.6 (9.45)
Sex: Female, Male (Count of Participants)
Female	38 48.1%	43 55.1%	43 52.4%	124 51.9%
Male	41 51.9%	35 44.9%	39 47.6%	115 48.1%

Outcome Measures

1. Primary Outcome

Title	Combined Rhinoconjunctivitis Symptom and Medication Score
Description	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
Time Frame	up to 6 weeks during the birch pollen season 2013

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	AllerT Low Dose	AllerT Full Dose
Arm/Group Description	SC injections of placebo placebo: SC injections of placebo on days 1, 7, 14, 28 and 56	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	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
Measure Participants	78	77	82
Mean (Standard Deviation) [score (maximum=3)]	0.86 (0.603)	0.64 (0.530)	0.72 (0.573)

2. Secondary Outcome

Title	Quality of Life
Description	mini-RQLQ questionnaires
Time Frame	up to 6 weeks during the birch pollen season 2013

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Safety and Tolerability
Description	Adverse 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
Time Frame	from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

Title	Immunological Markers: Specific IgE and IgG4
Description	blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4
Time Frame	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 2013

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Placebo		Allert 50 µg		AllerT 100 µg
Arm/Group Description	All patients having received at least one injection of Placebo (Safety Set)		All patients having received at least one injection of Allert 50 µg (Safety Set)		All patients having received at least one injection of Allert 100 µg (Safety Set)
All Cause Mortality
	Placebo		Allert 50 µg		AllerT 100 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Allert 50 µg		AllerT 100 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		1/78 (1.3%)		2/82 (2.4%)
Eye disorders
conjunctivitis	0/79 (0%)	0	1/78 (1.3%)	1	0/82 (0%)	0
Gastrointestinal disorders
Oropharyngeal discomfort	0/79 (0%)	0	1/78 (1.3%)	1	0/82 (0%)	0
Tongue oedema	0/79 (0%)	0	1/78 (1.3%)	1	0/82 (0%)	0
General disorders
Hypersensitivity	0/79 (0%)	0	0/78 (0%)	0	1/82 (1.2%)	1
Musculoskeletal and connective tissue disorders
Skull fracture	0/79 (0%)	0	0/78 (0%)	0	1/82 (1.2%)	1
Skin and subcutaneous tissue disorders
Urticaria	0/79 (0%)	0	1/78 (1.3%)	1	0/82 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		Allert 50 µg		AllerT 100 µg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/79 (74.7%)		70/78 (89.7%)		70/82 (85.4%)
Eye disorders
Conjunctivitis	5/79 (6.3%)		11/78 (14.1%)		12/82 (14.6%)
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis	14/79 (17.7%)		13/78 (16.7%)		16/82 (19.5%)
Rhinitis	7/79 (8.9%)		22/78 (28.2%)		25/82 (30.5%)
Dyspnea	5/79 (6.3%)		17/78 (21.8%)		25/82 (30.5%)
Cough	2/79 (2.5%)		12/78 (15.4%)		26/82 (31.7%)
Skin and subcutaneous tissue disorders
Injection site pain	26/79 (32.9%)		20/78 (25.6%)		16/82 (19.5%)
Injection site reaction	10/79 (12.7%)		19/78 (24.4%)		15/82 (18.3%)
Injection site erythema	18/79 (22.8%)		7/78 (9%)		11/82 (13.4%)
Pruritus	3/79 (3.8%)		20/78 (25.6%)		11/82 (13.4%)
Injection site oedema	9/79 (11.4%)		8/78 (10.3%)		13/82 (15.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI of the trial owns options in the sponsor company and is member of the Board of Anergis SA