Table Info

Table 2.

Monoclonal antibodies in advanced clinical trials for AD

Target	Drug	Route	Status	Global endpoints achieved	Reported adverse effects	References
IL-1α	Bermekimab	SC	Phase II	EASI-75, SCORAD-50	Wheezing, injection-site reaction, nausea	NCT03496974
IL-4α	Stapokibart	SC	Phase III	Ongoing	Ongoing	NCT06277765 NCT05265923
	Rademikibart	SC	Phase II	IGA 0/1	Headache, vomiting, injection-site reaction, eye pruritus	[72]
	611	SC	Phase III	Ongoing	Ongoing	NCT06173284
	AK120	SC	Phase I/II	EASI-75	Upper respiratory tract infection, headache, abdominal pain, mouth ulceration, injection-site reaction	[73] NCT05048056
	MG-K10	SC	Phase III	Ongoing	Ongoing	NCT06026891
	Dupilumab	SC	Approved	EASI-75; EASI-90	Conjunctivitis, injection-site reaction, nasopharyngitis, herpes viral infections, viral gastroenteritis, dental caries	[62, 74–79]
IL-13	Tralokinumab	SC	Approved	IGA 0/1; EASI-50; EASI-75; EASI-90	Viral upper respiratory tract infection, injection-site reaction, conjunctivitis	[80–82]
	Lebrikizumab	SC	Approved	IGA 0/1; EASI-75; EASI-90	Headache, oral herpes, conjunctivitis, nasopharyngitis, dry eye, folliculitis, upper respiratory tract infection	[83, 84]
	Eblasakimab	SC	Phase IIb	EASI-75	Not available	NCT05158023
IL-5Rα	Benralizumab	SC	Phase II	EASI-90	Bronchitis, conjunctivitis, Covid-19, nasopharyngitis, upper respiratory tract infection	NCT04605094
IL-12/IL-23p40	Ustekinumab	SC	Phase II	No significant efficacy	Upper respiratory tract infection, musculoskeletal pain	[71]
IL-17A	Secukinumab	SC	Phase II	No efficacy	Orbital cellulitis, upper respiratory infection, streptococcal pharyngitis	[85]
IL-22	Fezakinumab	SC	Phase IIa	SCORAD-50 in severe AD subpopulation	Viral upper respiratory tract infections, facial cellulitis	[68]
IL-22	LEO138559	SC	Phase IIb	Ongoing	Ongoing	NCT05923099
IL-23	Rizankisumab	SC	Phase II	No efficacy	Cellulitis, nasopharyngitis, pruritus	[86]
IL-31	Nemolizumab	SC	Approved (Japan)	EASI-90; IGA 0/1	Upper respiratory tract infection, nasopharyngitis	[87–91]
IL-33	Astegolimab	SC	Phase II	No efficacy	None recorded	[92]
	Etokimab	IV	Phase IIa	EASI-75	Headache, upper respiratory tract infection, conjunctivitis	[93]
	Tozorakimab	SC	Phase IIa	No efficacy	Oral herpes, cellulitis, conjunctivitis, nasopharyngitis, urinary tract infection	NCT04212169
	REGN3500	SC	Phase IIb	No efficacy	Peripheral oedema, nasopharyngitis	NCT03738423
IL-36R	Spesolimab	IV	Phase IIa	No significant efficacy	Upper respiratory tract infection, nasopharyngitis, depression	[94]
OX40	GBR830	SC	Phase IIb	No significant efficacy	Upper respiratory tract, myalgia, headache, postprocedural infection, fatigue	[95]
	Amlitelimab	IV	Phase IIa/b	EASI-75; IGA 0/1	Nasopharyngitis, Covid-19, headache, hyperhidrosis, upper respiratory tract infection, pyrexia, increased aspartate aminotransferase and iron deficiency anemia	[96, 97]
	Rocatinlimab	SC	Phase IIb	EASI-90	Atopic cataract, small intestine ulcer, pyrexia, vertigo, aphthous ulcer, constipation, diarrhea, vomiting, nausea, chills, nasopharyngitis, arthralgia, oropharyngeal pain	NCT03703102
IgE	Omalizumab	SC	Phase II	No significant efficacy	Viral infection, stomach pain, sore throat, toothache, urticaria, headache	[98–100]
mIgE	FB825	IV	Phase II	Not available	Not available	NCT04413942
TSLP	Tezepelumab	SC	Phase IIb	No significant efficacy	Headache, diarrhea, injection-site erythema	[101] NCT03809663
SCF	OpSCF	SC	Phase IIa	Ongoing	Ongoing	NCT06101823

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

Declarations

Author contributions

GTS: Conceptualization, Writing—original draft, Writing—review & editing. EAF and MM: Writing—original draft. KN: Writing—review & editing. SB: Conceptualization, Writing—review & editing, Supervision, Funding acquisition. All authors read and approved the submitted version.

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

This research was funded by the South African Research Chairs Initiative of the Department of Science and Technology (DST) and the National Research Foundation (NRF) [47904] of South Africa. The NRF and the South African Research Chair in Cancer Biotechnology have provided bursaries to support students contributing to this work. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright

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