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A prospective observational study on the long-term effectiveness and safety of inebilizumab for IgG4-related diseases in the real world setting in Japan (4SigHT study)

Effectiveness and Safety of Inebilizumab for IgG4-Related Disease in Real-World Clinical Setting in Japan: Protocol for a Long-Term Prospective Observational Study (4SigHT study)

Nagato Kazuo

Tanabe Pharma Corporation

3-2-10 Doshomachi Chuo-ku, Osaka-shi, Osaka, Japan

kazuo.nagato@tanabe-pharma.com

Nagato Kazuo

Tanabe Pharma Corporation

1-1-1 Marunouchi, Chiyoda-ku, Tokyo, Japan

+81-3-6748-7700

kazuo.nagato@tanabe-pharma.com

Recruiting

Mar. 01, 2026

Observational

Patients are eligible for inclusion if they meet all of the following criteria:
> Patients who have received sufficient explanation regarding participation in this study and have provided written informed consent.
> Patients diagnosed with IgG4 RD as 'definite' or 'probable' according to the comprehensive diagnostic criteria or organ-specific diagnostic criteria in effect at the time of consent.
> Patients who, at the time of consent, are scheduled to initiate treatment with inebilizumab (Uplizna IV infusion 100 mg) at a medical institution in Japan.
> Patients aged 18 years or older at the time of consent.
> Patients who have available medical records during at least the 52 weeks prior to initiation of inebilizumab, or, if disease onset occurred within 52 weeks prior to enrollment, patients who possess some form of medical record from the time of onset onward.

Patients are excluded if they meet any of the following criteria:
> Patients who lack the capacity to provide informed consent.
> Patients who fall under the contraindications for inebilizumab.
> Patients who have received B-cell-depleting therapy within the 6 months prior to the enrollment date, or who have received molecular targeted agents other than inebilizumab (excluding administration of inebilizumab in patients who have completed the OLP of the MITIGATE trial).
> Patients whom the investigator determines to be otherwise unsuitable for participation in this study.

Both

IgG4-Related Disease

Anti-CD19 monoclonal antibody; B-cell depletion; Observational study; IgG4-RD; IgG4-related disease; Inebilizumab

D000077733

The proportion of participants who experience an adjudicated clinical flare of IgG4-RD at Week 52 after receiving the first inebilizumab treatment.

Secondary Endpoints at Week 52
> Proportion of participants achieving complete remission (CR) without clinical flare and without requiring additional IgG4-RD-targeted therapies.
> Proportion of participants achieving CR without clinical flare and without the use of glucocorticoids.

Long-term Evaluations (From first dose to end of observation)
> Time to first clinical flare.
> Annualized clinical flare rate (ACFR) calculated as the number of adjudicated flares per patient-year.
> Treatment initiation for disease activity, and proportion of participants requiring new or escalated treatment (medication or intervention) for new or worsening IgG4-RD symptoms, regardless of Adjudication Committee (DSMB) flare determination, and time to initiation of such treatments.
> Cumulative glucocorticoid dose administered for the management of IgG4-RD throughout the study period.

+81-3-6416-1868

Jan. 22, 2026

No

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