Table 1.

Biologics for Atopic Dermatitis (Currently Approved or Completed Phase 3 Clinical Trials)

Biologic	Study Type	Trial Identifier	Subject Number	Duration (weeks)	Dose (%)	Age (years)	Primary Endpoints Achieved	Secondary Endpoints Achieved	Notable Adverse Events
Dupilumab	Phase 3 (monotherapy)	SOLO 1, NCT02277743	671	16 wks	300mg Q1W, Q2W	≥18	IGA 0/1	EASI 50/75/90, %EASI, BSA, SCORAD, PP-NRS 4, POEM, DLQI, HADS	Injection-site reactions, conjunctivitis
	Phase 3 (monotherapy)	SOLO 2, NCT02277769	708	16 wks	300mg Q1W, Q2W	≥18	IGA 0/1	EASI 50/75/90, %EASI, BSA, SCORAD, PP-NRS 4, POEM, DLQI, HADS	Injection-site reactions, conjunctivitis
	Phase 3 (+/−TCS)	LIBERTY AD CHRONOS, NCT02260986	740	52 wks	300mg Q1W, Q2W	≥18	IGA 0/1, EASI 75	%EASI, BSA, SCORAD, PP-NRS 4, POEM, DLQI, HADS	Injection site reactions, conjunctivitis
	Phase 3 (+TCS)	LIBERTY AD CAFÉ, NCT02755649	325	16 wks	300mg Q1W, Q2W	≥18	EASI 75	IGA 0/1, EASI 50/90, %EASI, BSA, SCORAD, PP-NRS 4, POEM, DLQI, HADS	Injection site reactions, conjunctivitis
	Phase 3 (monotherapy)	SOLOCONTINUE, NCT02395133	422	36 wks	300mg Q1W, Q2W, Q4W, Q8W	≥18	%EASI, EASI 75	IGA 0/1, %EASI, EASI 50, PP-NRS 3	Injection site reactions, conjunctivitis
	Phase 3 (monotherapy)	NCT03912259	165	16 wks	300mg	≥18	IGA 0/1	IGA 0/1, EASI 75, PP-NRS 4, BSA, DLQI, POEM	Conjunctivitis, nasopharyngitis, upper respiratory infection
	Phase 3 (monotherapy)	NCT03054428	251	16 wks	300mg Q2W, Q4W 200mg Q2W	12–17	IGA 0/1	EASI 50/75/90, %PP-NRS, PP-NRS 3, PP-NRS-4, SCORAD, CDLQI, POEM, HADS	Injection site pain, conjunctivitis
	Phase 3 (+TCS)	NCT03345914	367	16 wks	300mg Q4W, 200mg Q2W, 100mg Q2W	6 – 11	IGA 0/1	EASI 50/75/90, %EASI, %PP-NRS, PROMISanxiety/depression, SCORAD, CDLQI, POEM, DFI	Injection site pain, conjunctivitis
	Phase 3 (+TCS)	NCT03346434	162	16 wks	200mg Q4W	6 mo – 5 yrs	IGA 0/1	EASI 50/75/90, %EASI, %PP-NRS, PP-NRS 4, SCORAD, CDLQI, POEM,	Injection site pain, conjunctivitis
Tralokinumab	Phase 3 (monotherapy)	ECZTRA 1, NCT03131648	802	52 wks (16 wks initial + 36 wks maintenance)	300mg Q2W, Q4W	≥18	IGA 0/1, EASI 75	EASI 50/90, SCORAD 50/75, PP-NRS 4, DLQI	Conjunctivitis, nasopharyngitis, upper respiratory infection
	Phase 3 (monotherapy)	ECZTRA 2, NCT03160885	794	52 weeks (16 wks initial + 36 wks maintenance)	300mg Q2W, Q4W	≥18	IGA 0/1, EASI 75	EASI 50/90, SCORAD 50/75, PP-NRS 4, DLQI, IGA (maintenance), EASI 75 (maintenance)	Conjunctivitis, upper respiratory infection
	Phase 3 (+TCS)	ECZTRA 3, NCT03363854	380	32 weeks (16 wks initial + 16 wks continuation)	300mg Q2W, Q4W	≥18	IGA 0/1, EASI 75	EASI 50/90, SCORAD 50/75, PP-NRS 4, DLQI, TCS use	Conjunctivitis, upper respiratory infection, oral herpes, headache
	Phase 3 (+TCS)	ECZTRA 7, NCT03761537	277	26 weeks	300mg Q2W	≥18	EASI 75	IGA 0/1, SCORAD, DLQI	Injection site pain, conjunctivitis, headache
	Phase 3 (monotherapy)	NCT03526861	289	52 wks (16 wks initial + 36 wks maintenance)	150mg Q2W, Q4W, 300 mg Q2W, Q4W	12–17	IGA 0/1, EASI 75	EASI 50/90, %PP-NRS,PP-NRS 4,SCORAD, CDLQI,POEM	Injection site pain, conjunctivitis, headache, upper respiratory infection
Lebrikizumab	Phase 3 (monotherapy)	ADvocate 1, NCT04146363	424	52 weeks (16 wks induction + 36 wks maintenance)	250mg Q2W, Q4W	≥12	IGA 0/1, EASI 75	%EASI, EASI 90, SCORAD, BSA, %PP-NRS, PP-NRS 4, sleep loss, DLQI, CDLQI, POEM	Conjunctivitis
	Phase 3 (monotherapy)	ADvocate 2, NCT04178967	445	52 weeks (16 wks induction + 36 wks maintenance)	250mg Q2W, Q4W	≥12	IGA 0/1, EASI 75	%EASI, EASI 90, SCORAD, BSA, %PP-NRS, PP-NRS 4, sleep loss, DLQI, POEM	Conjunctivitis
	Phase 3 (+TCS)	ADhere, NCT04250337	228	16 weeks	250mg Q2W	12–17	IGA 0/1, EASI 75	%EASI, EASI 90, SCORAD, BSA, %PP-NRS, PP-NRS 4, sleep loss, DLQI, POEM	Conjunctivitis, headache
Nemolizumab	Phase 3 (+TCS/TCI)	JapicCTI-173740	215	68 weeks (16 wks + 52 wks OLE)	60mg Q4W	≥13	%VAS pruritus	Conclusions limited: no adjustment for multiple comparisons	Injection site reactions, cytokine abnormalities, increased creatinine kinase