Trial Outcomes & Findings for Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study (NCT NCT03682965)

Last Updated: 2021-04-20

Results Overview

The TCS is the preferred endpoint for rhinoconjunctivitis as recommended by the European Academy of Allergy and Clinical Immunology. Scoring of the TCS is from 0 to 38 on each day that it is assessed. The TCS is the sum of the symptom scores for "runny nose", "stuff nose", "sneezing", "itchy nose", "gritty/itchy eyes", and "watery eyes" rated from no symptoms = 0 to severe symptoms = 3 plus the score for use of rescue medications for allergy symptoms 6 points for oral antihistamine, 6 points for eye drops, and 8 points for a nasal corticosteroid. Thus, a lower score represents fewer symptoms and associated need for allergy medication, while a higher score reflects more severe symptoms and the use of medication to treat symptoms. The TCS will be measured during the 2018-2019 Mountain Cedar pollen se

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Up to 4 months

Results posted on

2021-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	Intra-lymphatic Allergenic Extract A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Overall Study STARTED	11	10
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=99 Participants	10 Participants n=107 Participants	21 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	34 years n=99 Participants	32 years n=107 Participants	33 years n=206 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	5 Participants n=107 Participants	12 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=99 Participants	9 Participants n=107 Participants	19 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Region of Enrollment United States	11 participants n=99 Participants	10 participants n=107 Participants	21 participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Population: Safety analysis included all participants who received at least one dose of study intervention. Efficacy analyses were on the per protocol dataset, which included participants who received three study treatment injections and completed at least 50% of expected electronic diary responses during the allergy season, with no major protocol violations. aLL enrolled patients met the criteria for inclusion in both the safety and per protocol analysis populations

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Average Daily Total Combined Score (TCS)	10.1 units on a scale Standard Deviation 3.3	13.0 units on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Assessed up to 4 months, number of actual peak pollen season days was 27

Evaluated during the 2018-2019 Texas Mountain Cedar allergy season. The number of days with a lower group average Total Combined Score, comparatively, in each Arm/Group are reported. Scoring of the TCS is from 0 to 38 on each day that it is assessed.The TCS is the sum of the symptom scores for "runny nose", "stuff nose", "sneezing", "itchy nose", "gritty/itchy eyes", and "watery eyes" rated from no symptoms = 0 to severe symptoms = 3 plus the score for use of rescue medications for allergy symptoms 6 points for oral antihistamine, 6 points for eye drops, and 8 points for a nasal corticosteroid. Thus, a lower score represents fewer symptoms and associated need for allergy medication, while a higher score reflects more severe symptoms and the use of medication to treat symptoms.

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Number of Peak Pollen Season Days With a Lower Group Average Total Combined Score	20 days	7 days

SECONDARY outcome

Timeframe: Immediately after the ILIT procedure

Patient reported pain will be measured immediately after ILIT procedure using the Numeric Rating Scale 11 (NRS-11 rating scale). The NRS-11 asks patients to rate their pain on a scale from 0 (no pain or discomfort) to 11 (worst possible pain).

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Patient Reported Pain or Discomfort Following Intra-lymphatic Injections	0.5 units on a scale Standard Deviation 0.5	0.5 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Up to 4 months

Percentage of patients reporting satisfaction with their treatment

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Patient-reported Treatment Satisfaction at the End of Study	91 percentage of participants	90 percentage of participants

SECONDARY outcome

Timeframe: Assessed prior to the first injection and to 4-8 weeks after the end of the 2018-2019 pollen season

Percentage change in allergen-specific serum IgE from baseline to the end-of-study visit between active ILIT and placebo.

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Percentage Change in Allergen-specific Serum IgE	148 percentage change in serum IgE Standard Deviation 214	201 percentage change in serum IgE Standard Deviation 231

SECONDARY outcome

Timeframe: 8 weeks

The total safety score is a is based on World Allergy Organization grading for allergic reactions. Following allergen or placebo exposure via intra-lymphatic injection, patients are monitored for local and systemic allergic reactions for up to 60 minutes post-procedure. At each exposure, a score is rated on a scale from none = 0, local reactions only = 1, mild systemic reactions (WAO Grade 1/2) = 2, moderate systemic reaction (WAO Grade 3) = 3, and severe systemic reaction (WAO grade 4) = 4. The total safety score for each group is the sum of the individual scores of each patient across all three treatments (exposures). Thus, the subject may have a score from 0 to 12 with 0 reflecting no allergic reaction to the allergen and 12 reflecting severe allergic reactions, and the TSS for a group is the sum for all patients in the group. The TSS is used to elicit and grade adverse events of interest rather than for statistical analysis.

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Total Safety Score (TSS) for Active and Placebo Treatment Groups	3 score on a scale	1 score on a scale

SECONDARY outcome

Timeframe: 8 weeks

To evaluate the safety of ILIT for Mountain Cedar pollinosis relative to placebo control based on the proportion of subjects receiving allergenic extract versus the proportion of subjects receiving placebo that: 1. experience anaphylaxis, or 2. are treated with epinephrine, or 3. experience any other treatment-emergent, serious adverse event (SAE) within 60 minutes of any of the three planned ILIT procedures.

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Number of Subjects Who: Experienced Anaphylaxis, Were Treated With Epinephrine, or Experienced Any Other Treatment-emergent SAE Within 60 Minutes of Any of Three Planned ILIT Procedures	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 month

Relative use of rescue inhalers by patients with comorbid asthma between active and placebo groups during the 2018-2019 Mountain Cedar pollen season.

Outcome measures

Outcome measures
Measure	Intra-lymphatic Allergenic Extract n=11 Participants A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 Participants Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Total Number of Rescue Inhaler Uses by Patients With Asthma	0 Rescue Inhaler Uses	0 Rescue Inhaler Uses

Adverse Events

Intra-lymphatic Allergenic Extract

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Intra-lymphatic Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intra-lymphatic Allergenic Extract n=11 participants at risk A series of three injections of 0.1 mL (about 2 drops) of the allergenic extract of Mountain Cedar Pollen given every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic allergenic extract: Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.	Intra-lymphatic Placebo n=10 participants at risk Diluent as placebo control (sterile saline solution containing 0.4% phenol as a preservative and matched concentration of glycerin) given as a series of three injections of 0.1 mL (about 2 drops) every four weeks into a superficial inguinal lymph node through guidance via ultrasonography using a 1-mL hypodermic syringe with a 25-gauge or smaller needle. Intra-lymphatic placebo: The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
Skin and subcutaneous tissue disorders Injection-site redness	27.3% 3/11 • Number of events 3 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.	0.00% 0/10 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.
Skin and subcutaneous tissue disorders Injection-site bruising	0.00% 0/11 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.	10.0% 1/10 • Number of events 1 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.
Cardiac disorders hypertension	9.1% 1/11 • Number of events 1 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.	0.00% 0/10 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.
General disorders peri-procedural anxiety	9.1% 1/11 • Number of events 2 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.	0.00% 0/10 • From the start of treatment (1st ILIT injection) through the end of the pollen season and for two months therafter, an average of 4 months per participant. In addition to spontaneous reporting and safety monitoring procedures, including vital signs assessments, Adverse Events of Interest were collected using the Total Safety Score worksheet during each injection procedure.

Additional Information

Mark Shapiro

Pharma Initiatives

Phone: 9193063675

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place