From:  Revisiting immunotherapeutic strategies for the management of atopic dermatitis
 

Monoclonal antibodies in advanced clinical trials for AD

TargetDrugRouteStatusGlobal endpoints achievedReported adverse effectsReferences
IL-1αBermekimabSCPhase IIEASI-75, SCORAD-50Wheezing, injection-site reaction, nauseaNCT03496974
IL-4αStapokibartSCPhase IIIOngoingOngoingNCT06277765
NCT05265923
RademikibartSCPhase IIIGA 0/1Headache, vomiting, injection-site reaction, eye pruritus[72]
611SCPhase IIIOngoingOngoingNCT06173284
AK120SCPhase I/IIEASI-75Upper respiratory tract infection, headache, abdominal pain, mouth ulceration, injection-site reaction[73]
NCT05048056
MG-K10SCPhase IIIOngoingOngoingNCT06026891
DupilumabSCApprovedEASI-75; EASI-90Conjunctivitis, injection-site reaction, nasopharyngitis, herpes viral infections, viral gastroenteritis, dental caries[62, 74–79]
IL-13TralokinumabSCApprovedIGA 0/1; EASI-50; EASI-75; EASI-90Viral upper respiratory tract infection, injection-site reaction, conjunctivitis[80–82]
LebrikizumabSCApprovedIGA 0/1; EASI-75; EASI-90Headache, oral herpes, conjunctivitis, nasopharyngitis, dry eye, folliculitis, upper respiratory tract infection[83, 84]
EblasakimabSCPhase IIbEASI-75Not availableNCT05158023
IL-5RαBenralizumabSCPhase IIEASI-90Bronchitis, conjunctivitis, Covid-19, nasopharyngitis, upper respiratory tract infectionNCT04605094
IL-12/IL-23p40UstekinumabSCPhase IINo significant efficacyUpper respiratory tract infection, musculoskeletal pain[71]
IL-17ASecukinumabSCPhase IINo efficacyOrbital cellulitis, upper respiratory infection, streptococcal pharyngitis[85]
IL-22FezakinumabSCPhase IIaSCORAD-50 in severe AD subpopulationViral upper respiratory tract infections, facial cellulitis[68]
LEO138559SCPhase IIbOngoingOngoingNCT05923099
IL-23RizankisumabSCPhase II No efficacyCellulitis, nasopharyngitis, pruritus[86]
IL-31NemolizumabSCApproved (Japan)EASI-90; IGA 0/1Upper respiratory tract infection, nasopharyngitis[87–91]
IL-33AstegolimabSCPhase IINo efficacyNone recorded[92]
EtokimabIVPhase IIaEASI-75Headache, upper respiratory tract infection, conjunctivitis[93]
TozorakimabSCPhase IIaNo efficacyOral herpes, cellulitis, conjunctivitis, nasopharyngitis, urinary tract infectionNCT04212169
REGN3500SCPhase IIbNo efficacyPeripheral oedema, nasopharyngitisNCT03738423
IL-36RSpesolimabIVPhase IIaNo significant efficacyUpper respiratory tract infection, nasopharyngitis, depression[94]
OX40GBR830SCPhase IIbNo significant efficacyUpper respiratory tract, myalgia, headache, postprocedural infection, fatigue[95]
AmlitelimabIVPhase IIa/bEASI-75; IGA 0/1Nasopharyngitis, Covid-19, headache, hyperhidrosis, upper respiratory tract infection, pyrexia, increased aspartate aminotransferase and iron deficiency anemia[96, 97]
RocatinlimabSCPhase IIbEASI-90Atopic cataract, small intestine ulcer, pyrexia, vertigo, aphthous ulcer, constipation, diarrhea, vomiting, nausea, chills, nasopharyngitis, arthralgia, oropharyngeal painNCT03703102
IgEOmalizumabSCPhase IINo significant efficacyViral infection, stomach pain, sore throat, toothache, urticaria, headache[98–100]
mIgEFB825IVPhase IINot availableNot availableNCT04413942
TSLPTezepelumabSCPhase IIbNo significant efficacyHeadache, diarrhea, injection-site erythema[101]
NCT03809663
SCFOpSCFSCPhase IIaOngoingOngoingNCT06101823
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EASI: eczema area and severity index; EASI 50/75/90: ≥ 50/75/90% improvement in EASI from baseline; IGA: investigator global assessment; IGA 0/1: “clear or almost clear” with ≥ 2-point improvement in IGA from baseline; IgE: immunoglobulin E; ILα: alpha chain of interleukin; ILRα: alpha chain of interleukin receptor; IV: intravenous; mIgE: membrane-bound immunoglobulin E; NCT: national clinical trial identifier consultable on www.clinicaltrials.gov (website consulted last time as of April 30, 2024), only clinical trials in advanced phases (Phase II onwards) are listed; SCF: stem cell factor; SC: subcutaneous; SCORAD: scoring atopic dermatitis; SCORAD 50: ≥ 50% improvement in SCORAD from baseline; TSLP: thymic stromal lymphopoietin