## Protocol Section
### Identification Module
**NCT ID:** NCT01111279

**Brief Title:** Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis

**Official Title:** Clinical Safety and Tolerability of gpASIT+TM Administered Subcutaneously in Absence or in Presence of DnaK Immunoregulating Adjuvant for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

#### Organization Study ID Info
**ID:** BTT-gpASIT004
#### Organization
**Class:** INDUSTRY
**Full Name:** BioTech Tools S.A.
### Status Module
#### Completion Date
**Date:** 2010-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-03-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-02-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Start Date
**Date:** 2010-03

**Status Verified Date:** 2011-02

#### Study First Post Date
**Date:** 2010-04-27
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-20
**Study First Submit QC Date:** 2010-04-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** BioTech Tools S.A.

#### Responsible Party

**Old Name Title:** Thierry Legon / CEO

**Old Organization:** BioTech Tools

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.

### Conditions Module

**Conditions:**

- Seasonal Allergic Rhinoconjunctivitis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 27

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Biological: Placebo solution

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Biological: gpASIT+TM

**Label:** gpASIT+TM

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Biological: gpAST+TM/adjuvant

**Label:** gpASIT+TM/adjuvant

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- gpASIT+TM

**Description:** 1 subcutaneous injection every 7 days, during 29 days.

**Name:** gpASIT+TM

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- gpASIT+TM/adjuvant

**Description:** 1 subcutaneous injection every 7 days, during 29 days

**Name:** gpAST+TM/adjuvant

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** 1 subcutaneous injection every 7 days, during 29 days

**Name:** Placebo solution

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** The following parameters will be assessed : general physical status, vital signs, haematological parameters , general blood biochemistry parameters, all (serious) adverse, immunological analysis (total IgG, total IgE) and inflammatory parameters (CRP, sedimentation rate)

**Measure:** Clinical tolerability and safety of the treatment

**Time Frame:** 3 times during the treatment phase, at week 24 (the end of the study)

#### Secondary Outcomes

**Description:** The following parameters will be assessed :

* allergen-specific IgE, IgG, IgG4, IgA antibody concentrations,
* adjuvant-specific IgG antibody concentrations,
* lymphoproliferation and production of IL-10 in allergen and adjuvant stimulated PBMC.

**Measure:** Impact of gpASIT+TM on the immunological status of the subjects

**Time Frame:** visit 1, week 7, week 18 and week 24

**Description:** The following parameters will be assessed (during the pollen season following treatment):

* daily average allergic symptom score,
* daily average allergic medication score,
* number of "well-days",
* Visual Analogue Scale .

**Measure:** Impact of gpASIT+TM on the clinical status of the subjects

**Time Frame:** 1 May - 15 August 2010

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject has given written informed consent
* Age between 18 and 50 years
* The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
* Male or non pregnant, non-lactating female
* Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
* Allergy diagnosis:

  * A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least during the two previous years
  * A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture
  * Specific IgE against grass pollen (RAST class 2 or IgE \> 0.7 kU/l)
  * Asymptomatic to perennial inhalant allergens even if shown to be hypersensitive in a skin prick test.

Exclusion Criteria:

* Subjects with current or past immunotherapy (any time in the past)
* A history of hypersensitivity to the excipients
* Subjects requiring control medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
* Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator)
* Subjects with a history of hepatic or renal disease
* Subjects symptomatic to perennial inhalant allergens
* Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent...)
* Subject with malignant disease, autoimmune disease (and family medical history of autoimmune disease)
* Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc...)
* Subjects requiring beta-blockers medication
* Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
* Subject with febrile illness (\> 37.5°C, oral)
* A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
* The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
* Receipt of blood or a blood derivative in the past 6 months preceding trial entry
* Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
* Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
* Use of long-acting antihistamines
* Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)
* Any condition which could be incompatible with protocol understanding and compliance
* Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
* Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
* Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
* Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start
* Subjects who participated to trial BTT-gpASIT003 and were in the treated groups

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Leuven

**Country:** Belgium

**Facility:** UZ Leuven, Gasthuisberg

**Zip:** 3000

#### Overall Officials

**Official 1:**

**Affiliation:** UZ Leuven

**Name:** Jan Ceuppens, Professor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6455

- Name: Conjunctivitis

- Relevance: HIGH

- As Found: Rhinoconjunctivitis

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003231

- Term: Conjunctivitis

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
