|
Drug
Mechanism of action | Phase trial
ClinicalTrials.gov identifier | (ratio), age, duration
TCS (yes/no/rescue) | Primary endpoint | % achieving primary endpoint | Parameters related to pruritus instead | TEAE | Interested TEAEs: atopic dermatitis |
|
Etokimab (ANB020)
Anti-IL-33 | Phase IIa [47, 48]
N/A | 12 (N/A), adults, 140 days
R | EASI 50 (day 29) | 83% | 5-D pruritus: | Headache | One patient had secondarily infected AD |
Phase IIb (ATLAS)
NCT03533751 | 300 (N/A), adults, 16 wks
N/A | EASI (week 16) | Failed | N/A | N/A | N/A |
|
Tralokinumab
Anti-IL-13 | Phase IIb [50]
NCT02347176 | 204 (1 : 1 : 1 : 1), adults, 12 wks
Y | EASI (week 12) | (Adjusted mean difference) 150 mg Q2W: -4.36,
300 mg Q2W: -4.94, | PP-NRS scores (week 12)
45 mg: -0.77,
300 mg: -1.14, | Most frequent TEAEs: URTI and headache
Pooled : nasopharyngitis, headache, and injection-site reaction | Placebo: 4 (7.8)
Pooled tralokinumab: 9 (5.9)
45 mg: 3 (6.0)
150 mg: 3 (5.9)
300 mg: 3 (5.8) |
Phase III [51]
ECZTRA 1 NCT03131648 | 802 (3 : 1), adults, 52 wks
R | IGA 0 or 1
EASI 75 (week 16) | IGA: 300 mg SC Q2W: 15.8% vs. placebo: 7.1%,
EASI 75: 300 mg: 25.0% vs. placebo: 12.7%, | PP-NRS ≥ 4-point (week 16)
300 mg Q2W: 20.0% vs. placebo: 10.3%, | : URTI, conjunctivitis
: atopic dermatitis, skin infection | Placebo: 75 (38·3)
Tralokinumab: 156 (25·9) |
Phase III [51]
ECZTRA 2 NCT03160885 | 794 (3 : 1), adults, 52 wks
R | IGA 0 or 1
EASI 75 (week 16) | IGA: 300 mg SC Q2W: 22.2% vs. placebo: 10.9%,
EASI 75: 300 mg: 33.2% vs. placebo: 11.4%, | PP-NRS ≥ 4-point (week 16)
300 mg Q2W: 25.0% vs. placebo: 9.5%, | : URTI, conjunctivitis
: atopic dermatitis, skin infection | Placebo: 67 (33.5)
Tralokinumab: 98 (16.6) |
Phase III [52]
ECZTRA 3 NCT03363854 | 380 (2 : 1), adults, 32 wks
Y | IGA 0 or 1
EASI 75 (week 16) | IGA: 300 mg SC Q2W: 38.9% vs. placebo: 26.2%,
EASI 75: 300 mg: 56.0% vs. placebo: 35.7%, | PP-NRS ≥ 4-point (week 16)
300 mg: 45.4% vs. placebo: 34.1%, | Viral upper respiratory tract infection, conjunctivitis, headache, URTI, and injection-site reaction | Placebo: 10 (7.9)
Tralokinumab: 6 (2.4) |
|
Lebrikizumab
Anti-IL-13 | Phase II [54]
TREBLE NCT02340234 | 209 (1 : 1 : 1 : 1), adults, 12 wks
Y | EASI 50 (week 12) | 125 mg SC Q4W: 82.4% vs. placebo 62.3%, ; 125 mg SC and 250 mg SC SD did not meet | Pruritus VAS (125 mg SD: -34.9%, 250 mg SD: -32.8%, 125 mg Q4W: -40.7% vs. placebo: -27.5%) was not statistically significant in all the groups | Conjunctivitis, herpetic infections, and eosinophilia occurred more often in lebrikizumab | N/A |
Phase IIb [55]
NCT03443024 | 280 (3 : 3 : 3 : 2), adults, 16 wks | EASI (week 16) | 125 mg SC Q4W: -62.3%,
250 mg SC Q4W: -69.2%,
250 mg SC Q2W: -72.1% () vs. placebo: -41.1% | PP-NRS ≥ 4-point (week 16)
125 mg Q4W: 41.8%,
250 mg Q4W: 47.4%,
250 mg Q2W: 70.0% () vs. placebo: 27.3% | Pooled : UPTI, nasopharyngitis, injection-site pain, and fatigue | N/A |
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