Trial Outcomes & Findings for Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy (NCT NCT01292070)

Results Overview

Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

4 participants

Primary outcome timeframe

up to 3 hours after the last injection of GFD

Results posted on

2014-02-20

Participant Flow

One center in Australia recruited four participants with a history of allergic reactivity to cats as expressed by allergic rhinitis and who had reactivity to standardized cat hair allergenic extract

Participant milestones

Participant milestones
Measure	Control (CAT) - Experimental (GFD) Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Evaluation of an Experimental Treatment, Intradermal Human Fcγ1-Fel d1 Fusion Protein (GFD), for Cat Allergy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control (CAT) - Experimental (GFD) n=4 Participants Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
Age, Continuous	25.3 years STANDARD_DEVIATION 2.4 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Australia	4 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 hours after the last injection of GFD

Population: The experimental protein (human Fcgamma1-Fel d1 fusion protein (GFD)) and the control protein (standardized cat hair allergenic extract (CAT)) elicited comparable reactivity in the first four participants dosed; thus, the trial was discontinued for futility and the primary endpoint was not evaluated

Difference in the doses of human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD) and standardized cat hair allergenic extract (CAT) required to elicit a wheal ≥ 10 mm with surrounding erythema.

Outcome measures

Outcome data not reported

Adverse Events

Control (CAT) - Experimental (GFD)

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	Control (CAT) - Experimental (GFD) n=4 participants at risk Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
Infections and infestations Rhinitis	25.0% 1/4 • Number of events 1 • Start of study through Day 28 Adverse events severities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (published May 28, 2009 and updated to 4.02 on September 15, 2009). Wheal, erythema, and pruritus at site of administration were expected outcomes and thus were not reported as adverse events

Additional Information

Nolan Sigal, MD, PhD, CEO, Tunitas Therapeutics

Tunitas Therapeutics

Phone: (650) 887-4747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place