Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Summary
Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-08
- Completion
- 2018-08-21
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo Patch vs 100 µg Peanut Patch; p = 0.005; Risk Difference (RD) 33.8 (33.8% CI 10.2 to 57.5) NCT01904604 ↗
registry analysis (superiority or other test); Placebo Patch vs 250 µg Peanut Patch; p = 0.003; Risk Difference (RD) 36.0 (36.0% CI 12.6 to 59.4) NCT01904604 ↗
Publications
- Background Keet CA, Wood RA. Emerging therapies for food allergy. J Clin Invest. 2014 May;124(5):1880-6. doi: 10.1172/JCI72061. Epub 2014 May 1.
- Results Jones SM, Sicherer SH, Burks AW, Leung DY, Lindblad RW, Dawson P, Henning AK, Berin MC, Chiang D, Vickery BP, Pesek RD, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA; Consortium of Food Allergy Research. Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. J Allergy Clin Immunol. 2017 Apr;139(4):1242-1252.e9. doi: 10.1016/j.jaci.2016.08.017. Epub 2016 Oct 26.
- Scurlock AM, Burks AW, Sicherer SH, Leung DYM, Kim EH, Henning AK, Dawson P, Lindblad RW, Berin MC, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA, Jones SM; Consortium for Food Allergy Research (CoFAR). Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research. J Allergy Clin Immunol. 2021 Mar;147(3):992-1003.e5. doi: 10.1016/j.jaci.2020.11.027. Epub 2020 Dec 5.
- Chiang D, Chen X, Jones SM, Wood RA, Sicherer SH, Burks AW, Leung DYM, Agashe C, Grishin A, Dawson P, Davidson WF, Newman L, Sebra R, Merad M, Sampson HA, Losic B, Berin MC. Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. J Allergy Clin Immunol. 2018 Jun;141(6):2107-2120. doi: 10.1016/j.jaci.2017.11.060. Epub 2018 Jan 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DEFATTED POWDER OF ARACHIS HYPOGAEA L., SEMEN (PEANUTS) | Protein / enzyme biologic | 100 ug | Topical |
| Subject | DEFATTED POWDER OF ARACHIS HYPOGAEA L., SEMEN (PEANUTS) | Protein / enzyme biologic | 250 ug | Topical |