The purpose of this Phase 3 study is to evaluate the safety and clinical efficacy of ligelizumab 240 mg and 120 mg given subcutaneously (s.c.) every 4 weeks (q4w) to ensure protection against allergic reaction by decreasing the sensitivity to oral…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the efficacy of ligelizumab 240 mg and 120 mg (SCq4w) compared to
placebo, as measured by the proportion of participants who can tolerate 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 (Section 16.4, Table 16-7) at Week 12
Secondary outcome
Key:
-To evaluate the efficacy of ligelizumab 240mg and 120mg (SCq4w), compared to
placebo, as measured by:
--the proportion of participants who can tolerate a single dose of >= 1000mg
(2044mg cum. tolerated dose) of peanut protein without dose limiting symptoms
during the double blind placebo controlled food challenge (DBPCFC) at w12
--the proportion of participants who can tolerate a single dose of 3000mg
(5044mg cum. tolerated dose) of peanut protein without doselimiting symptoms
during the DBPCFC at w12
--the maximum symptom severity at any single challenge dose up to and
including 1000mg of peanut protein during the DBPCFC at w12
-To evaluate the efficacy of 8 weeks of placebo treatment followed by 4 weeks
of ligelizumab 120mg and 240mg (SCq4w) treatment compared to 12 weeks of
placebo treatment, as measured by the proportion of participants who can
tolerate a single dose >=1000mg of peanut protein without dose-limiting symptoms
during the DBPCFC at w12
Other 2ndary objectives:
-listed in the clinical study protocol
Background summary
Currently, standard treatment for food allergy is limited to strict avoidance
of the allergen and emergency medication in case of accidental exposure.
However, accidental exposures of food-sensitive individuals to the very antigen
they are trying to avoid occur frequently.
Ligelizumab is a new agent, whose efficacy and safety in peanut allergy is
being investigated. Ligelizumab has not yet been approved ("registered") as a
medicine by the Dutch government. Doctors may not prescribe it to patients. For
registration, research with patients is needed. The results of this study will
be used for this.
More than 2,000 patients with various conditions, including persistent hives
and asthma, have so far been treated with ligelizumab in trials. The effects of
ligelizumab on peanut allergy have not been studied previously. We therefore do
not yet know whether it works in this condition.
Ligelizumab is a so-called monoclonal antibody. This is a protein that is made
in the laboratory to have a specific effect in the body. It is similar to some
proteins that are made by the body itself.
Study objective
The purpose of this Phase 3 study is to evaluate the safety and clinical
efficacy of ligelizumab 240 mg and 120 mg given subcutaneously (s.c.) every 4
weeks (q4w) to ensure protection against allergic reaction by decreasing the
sensitivity to oral peanut allergen in participants aged 6 to 55 years with
peanut allergy, compared to placebo. Data from this study, as well as data from
an additional Phase 3 study assessing two other major food allergens (milk and
egg), will support the registration of ligelizumab in food allergy to protect
participants against allergic reactions due to an accidental exposure
irrespective of the causative food allergen(s).
Study design
This is a 52-week, Phase 3 multi-center, randomized, double-blind and
placebo-controlled study to assess the safety and clinical efficacy of two
dosing regimens of ligelizumab (240 mg and 120 mg) SCq4w (subcutaneous
injection every 4 weeks) in participants with a medically confirmed diagnosis
of IgE-mediated peanut allergy. Approximately 486 participants will be
randomized to ligelizumab 240 mg, ligelizumab 120 mg, or placebo (5 treatment
arms, randomization ratio of 2:2:2:2:1) for the double-blind placebo-controlled
treatment period (up to Week 12). Participants initially assigned to the 8-week
placebo arms will receive the first dose of blinded ligelizumab treatment at
the Week 8 visit. Participants initially assigned to the 16-week placebo arm
will receive the last dose of placebo before the DBPCFC at week 12 and the
first dose of blinded ligelizumab treatment at the Week 16 visit.
Participants will be stratified based on region, total IgE at baseline (<350
IU/ mL; >=350 IU/ mL) and age (6-11y, 12-17y, and 18-55y). Approximately the
same number of participants will be randomized into each age group.
Intervention
* Ligelizumab 240 mg sc q4w
* Ligelizumab 120 mg sc q4w
* Placebo 0 mg sc q4w
Study burden and risks
- 14 s.c. injection every 4 weeks
- physical exam 8x
- vital signs: 24x
- length and/or weight measurments: 7x
- Blood draws: 8x , maximal 45 ml per visit
- Urinalysis: 5x
- stool sample examination: 2x from 3 different bowel movements
- ECG: 4x
- Scin Prick Test: 4x
- double blind placebo controlled food challenge: 3x
- Spirometry in co-morbid asthma only: 7x
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
- Male or female participants who are >= 6 and <= 55 years of age at the time of
signing informed consent/assent.
- Documented medical history of allergy to peanuts or peanut-containing foods.
- Positive peanut-specific immunoglobulin E (peanut sIgE), >= 3.5 kUA/L at
Screening visit 1 (Screening 1)
- 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.
- 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.
Eligibility to proceed with the DBPCFC requires fulfillment of all other
eligibility criteria.
- Participants must weigh >= 20 kg at Screening 1.
Exclusion criteria
- Total IgE >2000 IU/mL at Screening 1.
- History of severe or life-threatening hypersensitivity event needing an ICU
admission or intubation within 60 days prior to baseline DBPCFC (Screening
visit 2).
- 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-005339-56-NL |
| ClinicalTrials.gov | NCT04984876 |
| CCMO | NL78859.041.21 |