Module 1 (US) — Administrative & US Prescribing Information (OBX-319)

Document ID: M1-US
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): 21 CFR 201.57 (PLR)

US Prescribing Information (Highlights) — OBX-319

1 INDICATIONS AND USAGE. OBX-319 is indicated for the treatment of Systemic Lupus Erythematosus (moderate-to-severe active).

2 DOSAGE AND ADMINISTRATION. Administer by subcutaneous injection at the dose evaluated in the clinical programme; see Clinical Studies (14).

4 CONTRAINDICATIONS. Known serious hypersensitivity to the product or its excipients; active serious infection, including active tuberculosis.

6 ADVERSE REACTIONS.

Arm	N	≥1 TEAE	SAE	Deaths	Discontinued
OBX-319 High	162	78	2	1	17
OBX-319 Low	158	74	1	0	13
Placebo	160	78	1	0	10

Most frequent adverse events (subjects, by arm)

Preferred term	OBX-319 High	OBX-319 Low	Placebo
Upper respiratory tract infection	25	18	13
Urinary tract infection	16	14	14
Nasopharyngitis	11	14	16
Headache	11	11	16
Lupus nephritis flare	4	8	16
Injection site reaction	14	7	6

14 CLINICAL STUDIES. In OBX319-301, a randomized, double-blind, placebo-controlled study, the following efficacy was observed for SRI-4 response at Week 52 (operationalised as low disease activity, SLEDAI-2K <= 4):

Arm	N	LS-mean Δ SLEDAI-2K @ Wk 52 (points)	Diff vs placebo (95% CI)	p
OBX-319 High	162	-6.37	-2.91 (-3.12, -2.69)	0.0000
OBX-319 Low	158	-5.62	-2.17 (-2.38, -1.95)	0.0000
Placebo	160	-3.46	— (reference)	—

Responder analysis — Low disease activity (SLEDAI-2K <= 4)

Arm	N	Responders, n/N	Rate	Risk diff vs placebo (95% CI, %)	p
OBX-319 High	145	76/145	52.4%	46.4% (37.4, 55.4)	0.0000
OBX-319 Low	145	49/145	33.8%	27.8% (19.2, 36.4)	0.0000
Placebo	150	9/150	6.0%	— (reference)	—

Region-specific administrative content and the USPI are written to 21 CFR 201.57 (PLR); clinical figures trace to the Module 5 study report.