Table 1.

Phase 2b clinical trials of emerging therapies targeting the OX40-OX40L pathway.

Therapeutic Agent	Site of Action	Study Design		Primary Endpoint	Study Arms	Results
Rocatinlimab	OX40	NCT03703102 [23] Phase 2b multi-center, double-blind, placebo-controlled trial of 274 adults with moderate-to-severe AD randomized 1:1:1:1:1		Least-squares mean percent change in EASI from baseline to week 16	Placebo	−15.0% (95%CI, −28.6%–−1.4%)
					No LD 150 mg q4weeks	−48.3% (95%CI, −62.2%–−34.0%) p = 0.0003
					No LD 600 mg q4weeks	−49.7% (95%CI, −64.3%–−35.2%) p = 0.0002
					No LD 300 mg q2weeks	−61.1% (95%CI, −75.2%–−47.0%) p < 0.0001
					No LD 600 mg q2weeks	−57.4% (95%CI, −71.3%–−43.4%) p < 0.0001
Telazorlimab	OX40	NCT03568162 [93] Phase 2b multi-center, double-blind, placebo-controlled trial of adults with moderate-to-severe AD	Part 1 313 subjects randomized 1:1:1:1	Least-squares mean percent change in EASI from baseline to week 16	Placebo	−34.2% (SE 5.5)
					LD: 150 mg 75 mg q4weeks	−31.0% (SE 5.7) p = 0.691
					LD: 600 mg 300 mg q4weeks	−48.6% (SE 5.4) p = 0.061
					LD: 600 mg 300 mg q2weeks	−54.4% (SE 5.1) p = 0.008
			Part 2 149 subjects randomized 1:1	Least-squares mean percent change in EASI from baseline to week 16	Placebo	−41.8% (SE 4.7)
					LD: 1200 mg 600 mg q2weeks	−59.0% (SE 4.6) p = 0.008
Amlitelimab	OX40L	NCT05131477 [95] Phase 2b multi-center, double-blind, placebo-controlled trial of 390 adults with moderate-to-severe AD randomized 1:1:1:1:1		Least-squares mean percent change in EASI from baseline to week 16	Placebo	−29.4%
					LD: 500 mg 250 mg q4weeks	−61.5% p < 0.0001
					No LD 250 mg q4weeks	−56.8% p < 0.0001
					No LD 125 mg q4weeks	−51.6% p = 0.0002
					No LD 62.5 mg q4weeks	−59.6% p < 0.0001

Abbreviations: AD, atopic dermatitis; EASI, Eczema Area and Severity Index; LD, loading dose; q2weeks, every two weeks; q4weeks, every four weeks; 95%CI, 95% confidence interval; SE, standard error.