Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000024265
• Date of registration: 04/10/2016
• Prospective Registration: Yes
• Primary sponsor: Department of Dermatology, Keio University School of Medicine
• Public title: Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus
• Scientific title: Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus - Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus
• Date of first enrolment: 2016/10/04
• Target sample size: 10
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027938
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase II

Countries of recruitment

Japan

Contacts

• Name: Yasuko Saito
• Affiliation: Keio University Hospital Clinical and Translational Research Center

• Name: Masayuki Amagai
• Affiliation: Department of Dermatology, Keio University School of Medicine Dermatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Women who are nursing, pregnant, intending to be pregnant. 2. Patients with a history of hypersensitivity or shock to humanized or mouse monoclonal antibodies or mouse-derived components. 3. Patients with severe and uncontrollable organ failure. 4. Patients with any concomitant condition that required treatment. 5. Patients with an active infection. 6. Patients who received an infusion of antibiotics or patients with an infectious disease that requires hospitalization. 7. Patients who received an oral administration of antibiotics. 8. Patients with a history of a bacteremia caused by Staphylococcus aureus or Pseudomonas aeruginosa. 9. Patients who experienced bone soft tissue infections or any type of organ abscess. 10. Patients with a history of severe recurrent infection or chronic infection. 11. Patients with a malignant tumor or a history of a malignant tumor. 12. Patients with a history of addiction to alcohol or drugs. 13. Patients with a severe psychiatric disorder. 14. Patients in whom an operative treatment has been performed. 15. Patients with a history of severe infection after starting immunosuppressive agent administration. 16. Patients who previously received administration of anti-CD20 antibody. 17. Patients who have used a live vaccine or attenuated vaccine. 18. Patients in whom the following clinical laboratory abnormalities are noted during the SCR period. 19. Patients who have begun or increased the dose of an oral immunosuppressive agent. 20. Patients who received IVIG. 21. Patients who received intravenous steroid pulse therapy. 22. Patients who received plasmapheresis. 23. Patients who received intravenous cyclophosphamide pulse therapy . 24. Patients treated with other investigational drugs. 25. Patients who are determined as unfit for the enrollment in the study after an investigation.

Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

steroid treatment-resistant pemphigus

Intervention(s)

Rituximab (genetic recombination)

Primary Outcome(s)

The percentage of patients who achieve remission (complete remission + partial remission) at Week 25

Secondary Outcome(s)

>Pemphigus Disease Area Index (PDAI) values at Week 25 >Changes from baseline in PDAI >Changes from baseline in pemphigus autoantibody values (anti-Dsg1,anti-Dsg3 autoantibodies) >Changes from baseline in CD19+ B-cell counts, CD20+ B-cell counts, and CD3+ T-cell counts Safety endpoints: >Type, frequency, and severity of adverse events >Type, frequency, and severity of adverse drug reactions Other endpoints: >Pharmacokinetic analysis (changes in peripheral blood concentration of IDEC-C2B8) >Expression rate of human anti-IDEC-C2B8 antibody (HACA) >Changes from baseline in immunoglobulin values

Source(s) of Monetary Support

Japan Agency Medical Research and Development

ZENYAKU KOGYO CO.,LTD.

Secondary Sponsor(s)

HOKKAIDO UNIVERSITY HOSPITAL OKAYAMA UNIVERSITY HOSPITAL KURUME UNIVERSITY HOSPITAL

Ethics review

Status: YES
Approval date: 01/09/2016
Contact:

Results

• Results available: Yes
• Date Completed: 31/03/2019