About the ZENITH Study
ZENITH is a clinical research trial that will test whether the drug tezepelumab given with peanut oral immunotherapy (OIT) can help treat peanut allergy by improving the tolerability, effectiveness, and durability of OIT. Adolescents and adults may not respond as well to treatment with only peanut OIT. Researchers want to see if after two years of this combination treatment, people 12 to 55 years of age with peanut allergy become less sensitive to peanuts and lower the risk of life-threatening allergic reactions.
The Study Drug
ZENITH investigates the use of tezepelumab with peanut OIT to determine whether the combination will improve the tolerability and effectiveness of taking peanut OIT, and durability of oral desensitization. Tezepelumab is an antibody that blocks the thymic stromal lymphopoetin (TSLP). TSLP is a signaling molecule that is expressed in the gut, skin, and airways and is an important driver of the allergic response in these tissues. Tezepelumab has been approved by the FDA for use in asthma. However, because it has not been approved for use in food allergy, it is considered an experimental drug.
Participating in ZENITH
Peanut allergic study participants between the ages of 12 and 55 will be randomly assigned to one of two groups. Initially, one group will receive tezepelumab and the other will receive placebo. After 8 weeks, peanut OIT will be added to each group for a period of 56 weeks. Then, participants will stop taking both tezepelumab/placebo and OIT for 12 weeks.
Allergy to peanut will be assessed by a food challenge three times during the study:
- At screening, to assess peanut allergy
- The end of the 56-week combination therapy period
- Following the 12-week experimental drug withdrawal
Throughout the study, blood, urine, and saliva samples will be collected, and skin prick tests will be conducted.