A 52 week, multi-center, randomized, double-blind placebocontrolled study to assess the clinical efficacy and safety of ligelizumab (QGE031) in decreasing the sensitivity to peanuts in patients with peanut allergy

JRCT ID: jRCT2031210532

Registered date:26/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: peanut allergy
• Date of first enrollment: 04/03/2022
• Target sample size: 18
• Countries of recruitment: Australia,Japan,Canada,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,South Africa,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: ligelizumab
Subcutaneous injection once every 4 weeks
Drug: Placebo
Subcutaneous injection once every 4 weeks

Outcome(s)

Primary Outcome

Proportion of participants who can tolerate a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms at Week 12.
Responder status is defined as tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC) conducted at Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 55age old
• Gender: Both

Include criteria

1. Male or female participants who are >= 6 and =< 55 years of age at the time of signing informed consent/assent.
2. Documented medical history of allergy to peanuts or peanut-containing foods.
3. Positive peanut-specific immunoglobulin E (peanut sIgE), >= 6 kUA/L at Screening visit 1 (Screening 1).
4. Positive skin prick test (SPT) for peanut allergen at Screening 1 defined as an average diameter (Longest diameter and mid-point orthogonal diameter) >= 4 mm wheal compared to saline control.
5. A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose =< 100 mg of peanut protein, and no occurrence on placebo. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.
6. Participants must weigh >= 20 kg at Screening 1.

Exclude criteria

1. Total IgE >2000 IU/mL at Screening 1.
2. History of severe or life-threatening hypersensitivity event needing an ICU admission or intubation within 60 days prior to baseline DBPCFC (Screening visit 2).
3. Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who meet any of the following criteria:
- FEV1 <80% of subject's predicted normal value at Screening visit 1
- One hospitalization for asthma within 12 months prior to Screening visit 1

Related Information

• Primary Sponsor: Hiroyuki Yamada
• Secondary ID(s): NCT04984876