A Phase I study to assess in vitro and in vivo immunoreactivity of Ruconest in Subjects with cow's milk allergy (CMA) and/or rabbit allergy (RA)

A Phase I study to assess in vitro and in vivo immunoreactivity of Ruconest in Subjects with cow's milk allergy (CMA) and/or rabbit allergy (RA) - Ruconest skin prick test validation protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39068

Enrollment

Registered

2011-09-01

Start date

2012-04-10

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's milk allergy and rabbit allergy

Interventions

SPT, ICT, and subcuteanous test with Ruconest

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Positive SPT and/or IgE >0.35 for CM and/or positive SPT and/or IgE >0.35 for rabbit dander • Signed written informed consent • Males and females between 18 and 65 years old • Medical records documenting clinical CMA and/or RA or suggestive history of symptoms • Physical examination findings within normal limits • Willingness and ability to comply with all protocol procedures

Exclusion criteria

Exclusion criteria: • Pregnancy or breastfeeding, or current intention to become pregnant • Severe dermographism • Other concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to individuals in this study • Treatment with drugs that interfere with skin test response • History or symptoms of significant psychiatric disease, including depression and schizophrenia • Known or suspected addiction to drug and/or alcohol abuse • Participation in an investigational drug or device trial within the last 30 days prior to screening

Design outcomes

Primary

Measure	Time frame
Reactivity by both skin test procedures and severity of adverse events (AEs) following subcutaneous challenge. Number of subjects who experienced a positive skin reaction, as measured by a >= 3-mm wheal over the negative control (SPT) and/or an erythema that equals or exceeds in mean diameter the positive control (ICT). Endpoint will be evaluated by recording local reactions and systemic symptoms of type I hypersensitivity. The negative predictive value of the skin test protocol will be assessed as the number of subjects without systemic reaction upon subcutaneous challenge over the number of subjects having tested negative for the SPT and ICT.	—

Measure

Time frame

Reactivity by both skin test procedures and severity of adverse events (AEs) following subcutaneous challenge. Number of subjects who experienced a positive skin reaction, as measured by a >= 3-mm wheal over the negative control (SPT) and/or an erythema that equals or exceeds in mean diameter the positive control (ICT). Endpoint will be evaluated by recording local reactions and systemic symptoms of type I hypersensitivity. The negative predictive value of the skin test protocol will be assessed as the number of subjects without systemic reaction upon subcutaneous challenge over the number of subjects having tested negative for the SPT and ICT.

—

Secondary

Measure	Time frame
NVT	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)