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The trial is taking place at:
A

Aventiv Research | Aventiv Research Columbus

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Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy

A

ALK-Abelló

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Peanut Allergy

Treatments

Other: Placebo
Biological: Peanut SLIT-tablet

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.

Full description

This is a phase I/II, dose-escalation, multi-site trial including subjects with peanut allergy confirmed by screening double-blind, placebo-controlled food challenge. The trial is conducted in 3 parts; part 1 will determine the entry dose of the up-dosing regimen (UDR) in adults and adolescents; part 2 will characterize the tolerability of the up-dosing regimen in adults, adolescents and children; part 3 will evaluate the efficacy of 2 maintenance doses of the SLIT-tablet primarily in adolescents and children; a small number of adults may also be included.

Peanut SLIT tablets administered as 9 doses covering a 4000-fold increase in dose will be used in the study.

In part 1, subjects will receive a peanut SLIT-tablet with one of five doses once daily for 2 weeks.

In part 2, subjects will receive a series of increasing doses of the peanut SLIT-tablet, where each dose is taken once daily for 2 weeks. The entry dose for the up-dosing regimen will be determined from part 1.

In part 3, subjects will be randomized into 3 treatment groups (UDR and Maintenance A, UDR and Maintenance B, Placebo UDR and Placebo). Subjects will receive a series of increasing doses of the peanut SLIT-tablet , where each dose is taken once daily for 2 weeks, followed by Maintenance A or B once daily for 24 weeks; or the corresponding Placebo.

The trial will consist of up to 10 cohorts (part 1 is cohort 1-5; part 2 is cohort 6-10) and 3 treatment groups in part 3.

Enrollment

192 estimated patients

Sex

All

Ages

4 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

KEY INCLUSION CRITERIA:

Subjects are eligible to be included in the trial only if all the following criteria apply:

  • Part 1: Male or female aged 12 through 65 years (inclusive) on the day of enrollment Part 2: Male or female aged 4 through 65 years (inclusive) on the day of enrollment Part 3: Male or female aged 4 through 65 years (inclusive) on the day of randomization
  • Documented clinical history of an IgE-mediated allergic reaction towards peanut- containing food
  • Peanut-specific serum IgE ≥ 0.7 kU/L at screening measured at central laboratory
  • Skin prick test to peanut ≥ 5 mm at screening
  • Cohorts 1-8: Experience dose-limiting symptoms at the 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC Cohorts 9-10: Experience dose-limiting symptoms at the 1 mg or 3 mg challenge dose of peanut protein on the screening DBPCFC Part 3: Experience dose-limiting symptoms at the 3 mg, 10 mg, 30 mg or 100 mg challenge dose of peanut protein on screening DBPCFC

KEY EXCLUSION CRITERIA:

Subjects are excluded from the trial if any of the following criteria apply:

  • Diagnosis or history of eosinophilic esophagitis

  • Uncontrolled asthma as defined by the Asthma Control Test questionnaire with a score of 19 or below at enrollment (subjects with a diagnosis of asthma only)

  • All subjects ≥ 5 years old with FEV1 or PEFR < 70% of predicted value at enrollment Subjects 4 years old with a history of recurrent wheeze requiring inhaled corticosteroids for 2 consecutive weeks or more within 3 months prior to enrollment

  • Up-dosing with any allergy immunotherapy product. Maintenance dose of any subcutaneous immunotherapy product other than peanut is allowed

  • History of peanut oral immunotherapy within the last 12 months prior to visit 1

  • Chronic or acute oral inflammation at enrollment

  • History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension

  • Currently using any prohibited medication on the list of prohibited medication

  • Part 1 and 2: Allergic symptoms in reaction to the placebo part of the screening DBPCFC Part 3: Dose-limiting allergic symptoms in reaction to the placebo part of the screening DBPCFC

  • History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of the screening DBPCFC

  • Part 1 and 2: Asthma according to below criteria:

    • Severe asthma as per the current GINA guidelines
    • Uncontrolled or poorly controlled asthma as per the current GINA guidelines
    • Asthma that requires more than a daily dose above 800 µg of inhaled budesonide (or clinically comparable inhaled corticosteroids)
    • History of 2 or more systemic corticosteroid courses within 6 months of screening
    • Prior intubation/mechanical ventilation for asthma
    • Emergency room visit or hospitalization for asthma in the 12 months prior to screening
    • Any history of a life-threatening asthma attack
  • Part 3: Asthma fulfilling the below criteria:

    • History of 2 or more systemic corticosteroid courses within 6 months of screening
    • Prior intubation/mechanical ventilation for asthma
    • Emergency room visit or hospitalization for asthma in the 12 months prior to screening
    • Any history of a life-threatening asthma attack
    • (US only) Severe asthma as per the current GINA guidelines
    • (US only) Uncontrolled or poorly controlled asthma as per the current GINA guidelines
    • (US only) Asthma that requires more than a daily maintenance dose above 800 μg of inhaled budesonide (or clinically comparable inhaled corticosteroids)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

192 participants in 13 patient groups, including a placebo group

Part 1: Cohort 1
Experimental group
Description:
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Treatment:
Biological: Peanut SLIT-tablet
Part 1: Cohort 2
Experimental group
Description:
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Treatment:
Biological: Peanut SLIT-tablet
Part 1: Cohort 3
Experimental group
Description:
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Treatment:
Biological: Peanut SLIT-tablet
Part 1: Cohort 4
Experimental group
Description:
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Treatment:
Biological: Peanut SLIT-tablet
Part 1: Cohort 5
Experimental group
Description:
Adults and adolescents - peanut SLIT-tablet once daily for 2 weeks
Treatment:
Biological: Peanut SLIT-tablet
Part 2: Cohort 6
Experimental group
Description:
Adults - UDR with once daily peanut SLIT-tablet
Treatment:
Biological: Peanut SLIT-tablet
Part 2: Cohort 7
Experimental group
Description:
Adolescents - UDR with once daily peanut SLIT-tablet
Treatment:
Biological: Peanut SLIT-tablet
Part 2: Cohort 8
Experimental group
Description:
Children - UDR with once daily peanut SLIT-tablet
Treatment:
Biological: Peanut SLIT-tablet
Part 2: Cohort 9
Experimental group
Description:
Highly sensitized Adults/Adolescents - UDR with once daily peanut SLIT-tablet
Treatment:
Biological: Peanut SLIT-tablet
Part 2: Cohort 10
Experimental group
Description:
Highly sensitized Children - UDR with once daily peanut SLIT-tablet
Treatment:
Biological: Peanut SLIT-tablet
Part 3: Maintenance A
Experimental group
Description:
UDR A + maintenance dose A
Treatment:
Biological: Peanut SLIT-tablet
Part 3: Maintenance B
Experimental group
Description:
UDR B + maintenance dose B
Treatment:
Biological: Peanut SLIT-tablet
Part 3: Placebo
Placebo Comparator group
Description:
Placebo UDR + placebo maintenance
Treatment:
Other: Placebo

Trial contacts and locations

25

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Central trial contact

Clinical Project Manager

Data sourced from clinicaltrials.gov

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