Details of the Drug Reposition

General Information of This Drug (ID: DM0DYAX)

• Drug Name: Nipocalimab? (DM0DYAX)
• Drug Type: Monoclonal antibody

Information on Drug Reposition of This Drug

3 Phase 3 Indication(s)

Indication Name	Indication ID	ICD-11	Status	REF
Warm autoimmune hemolytic anemia	DISQJXI8	3A20.0	Phase 3	[1]
Chronic inflammatory demyelinating polyneuropathy	DISNGBLD	8C01.3	Phase 3	[2]
Generalized myasthenia gravis	DISQOYF5	8C60	Phase 3	[3]

4 Phase 2 Indication(s)

Indication Name	Indication ID	ICD-11	Status	REF
Systemic lupus erythematosus	DISI1SZ7	4A40.0	Phase 2	[4]
Idiopathic inflammatory myopathy	DISGB1BZ	4A41	Phase 2	[5]
Sjogren syndrome	DISUBX7H	4A43.20	Phase 2	[6]
Rheumatoid arthritis	DISTSB4J	FA20	Phase 2	[7]

References

• [1] ClinicalTrials.gov (NCT04119050) Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With a Long-term Open-label Extension. U.S.National Institutes of Health.
• [2] ClinicalTrials.gov (NCT05327114) Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). U.S.National Institutes of Health.
• [3] ClinicalTrials.gov (NCT05265273) An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis. U.S.National Institutes of Health.
• [4] ClinicalTrials.gov (NCT04882878) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus. U.S.National Institutes of Health.
• [5] ClinicalTrials.gov (NCT05379634) A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies. U.S.National Institutes of Health.
• [6] ClinicalTrials.gov (NCT04968912) A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS). U.S.National Institutes of Health.
• [7] ClinicalTrials.gov (NCT04991753) A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy. U.S.National Institutes of Health.