. 2022 Apr 5;88(8):3803–3812. doi: 10.1111/bcp.15332

TABLE 1.

Overview of inebilizumab clinical studies

Study no.	Study design	Dose(s)	Number of subjects	Serum sampling schedule
MI‐CP200: Study CP200	A phase 1, randomized, double‐blind, placebo‐controlled study of the safety and tolerability of inebilizumab in SSc	Single IV dose of inebilizumab (0.1, 0.3, 1.0, 3.0 or 10.0 mg kg⁻¹) or placebo.	28 subjects were enrolled into the study, with 5 cohorts of subjects receiving 1 of 5 single IV doses of inebilizumab (0.1, 0.3, 1.0, 3.0 or 10.0 mg kg⁻¹) or placebo	PK at predose, 30 min after the end of the infusion on d 1, and on d 3, 8, 15, 29, 57 and 85 ADA on d 1, 29, 57, 85
CD‐IA‐MEDI‐551‐1102: Study 1102	A phase 1, multicentre, multinational, randomized, blinded, placebo‐controlled, dose‐escalation study to evaluate the safety and tolerability of inebilizumab in adult subjects with relapsing forms of MS	IV infusion of inebilizumab (30, 100 or 600 mg) or placebo on d 1 and 15, or Single s.c. administration of inebilizumab (60 or 300 mg) or placebo on d 1	28 subjects were enrolled in the study. Among them 21 received inebilizumab (15 IV and 6 s.c.) and 7 received placebo.	PK at predose and 15 min after the end of infusion (IV Cohorts only) on d 1 and d 15, and on d 4 (SC Cohorts only), 8, 29, 57, 85, 113, 141 and 169 ADA on d 1 (predose), 29, 85 and 169, and at 3, 6, 9, 12, 15 and 18 mo during the LTFU period
CD‐IA‐MEDI‐551‐1155: Study 1155 (N‐MOmentum study)	A phase 2/3, randomized, double‐masked, placebo‐controlled study followed by open label period to evaluate the efficacy, safety and tolerability of inebilizumab in adult subjects with NMOSD	IV infusion of inebilizumab (300 mg) or placebo on d 1 and 15 of RCP	230 subjects with NMOSD were enrolled, randomized, and dosed in a 3:1 ratio to receive inebilizumab or placebo for 197 d (RCP).	PK at predose and 15 min after the end of infusion on d 1 and d 15, and on d 8, 29, 57, 85, 113, 155 and 197 of RCP ADA on d 1 (predose), 29, 85 and 197 of RCP, and at wk 0, 13, 26, 39 and 52 during the OLP then every 3 mo for 1 y post‐last dose in SFP

Study no.

Study design

Dose(s)

Number of subjects

Serum sampling schedule

MI‐CP200: Study CP200

A phase 1, randomized, double‐blind, placebo‐controlled study of the safety and tolerability of inebilizumab in SSc

Single IV dose of inebilizumab (0.1, 0.3, 1.0, 3.0 or 10.0 mg kg⁻¹) or placebo.

28 subjects were enrolled into the study, with 5 cohorts of subjects receiving 1 of 5 single IV doses of inebilizumab (0.1, 0.3, 1.0, 3.0 or 10.0 mg kg⁻¹) or placebo

PK at predose, 30 min after the end of the infusion on d 1, and on d 3, 8, 15, 29, 57 and 85

ADA on d 1, 29, 57, 85

CD‐IA‐MEDI‐551‐1102:

Study 1102

A phase 1, multicentre, multinational, randomized, blinded, placebo‐controlled, dose‐escalation study to evaluate the safety and tolerability of inebilizumab in adult subjects with relapsing forms of MS

IV infusion of inebilizumab (30, 100 or 600 mg) or placebo on d 1 and 15, or

Single s.c. administration of inebilizumab (60 or 300 mg) or placebo on d 1

28 subjects were enrolled in the study. Among them 21 received inebilizumab (15 IV and 6 s.c.) and 7 received placebo.

PK at predose and 15 min after the end of infusion (IV Cohorts only) on d 1 and d 15, and on d 4 (SC Cohorts only), 8, 29, 57, 85, 113, 141 and 169

ADA on d 1 (predose), 29, 85 and 169, and at 3, 6, 9, 12, 15 and 18 mo during the LTFU period

CD‐IA‐MEDI‐551‐1155: Study 1155 (N‐MOmentum study)

A phase 2/3, randomized, double‐masked, placebo‐controlled study followed by open label period to evaluate the efficacy, safety and tolerability of inebilizumab in adult subjects with NMOSD

IV infusion of inebilizumab (300 mg) or placebo on d 1 and 15 of RCP

230 subjects with NMOSD were enrolled, randomized, and dosed in a 3:1 ratio to receive inebilizumab or placebo for 197 d (RCP).

PK at predose and 15 min after the end of infusion on d 1 and d 15, and on d 8, 29, 57, 85, 113, 155 and 197 of RCP

ADA on d 1 (predose), 29, 85 and 197 of RCP, and at wk 0, 13, 26, 39 and 52 during the OLP then every 3 mo for 1 y post‐last dose in SFP

ADA, anti‐drug antibody; IV, intravenous; LTFU, long‐term follow‐up; MS, multiple sclerosis; No., number; MEDI‐551, inebilizumab; NMO, neuromyelitis optica; NMOSD, neuromyelitis optica spectrum disorders; OLP, open label period; PK, pharmacokinetic; RCP, randomized controlled period; s.c., subcutaneous; SFP, safety follow‐up period; SSc, systemic sclerosis.