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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024265
Receipt No. R000027938
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
Date of disclosure of the study information 2016/10/04
Last modified on 2018/12/18

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Basic information
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
Acronym 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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition steroid treatment-resistant pemphigus
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of IDEC-C2B8 in patients with pemphigus who are refractory to steroid therapy (except for paraneoplastic pemphigus)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The percentage of patients who achieve remission (complete remission + partial remission) at Week 25
Key secondary outcomes >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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rituximab (genetic recombination)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who were definitively diagnosed of pemphigus during receive PSL with/without "minimal immunosuppressive adjuvant as necessary" (refer to Table 6 1) and experienced disease relapse and a re-increase in the PDAI score during the course of PSL tapering after remission induction. (However, this is limited to the PDAI score at the time of obtaining consent was 1 point or higher and less than 50 points).
2. Patients who receive standard-of-care PSL consisting of 15-30 mg/day.
3. Patients who have persistent or worse PDAI score at two consecutive points at an interval of at least 7 days during a screening period (allowable variation range: PDAI score within 3 times and a difference of +20 points from the time of tentative registration).
4. Male or female aged from 20 to 80 years
5. Patients who are able to be hospitalized for 3 days (2 night) from the date of the initial administration of IDEC-C2B8 (inpatient or outpatient treatment is possible for second administration).
6. Patients in whom the stable dose of PSL for at least 30 days prior to screening.
7. Patients who signed informed consent form.
Key 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.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Amagai
Organization Department of Dermatology,
Keio University School of Medicine
Division name Dermatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL 03-3353-1211
Email amagai@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Saito
Organization Keio University Hospital
Division name Clinical and Translational Research Center
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL 03-5315-4278
Homepage URL
Email pmo@ccr.med.keio.ac.jp

Sponsor
Institute Department of Dermatology,
Keio University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor HOKKAIDO UNIVERSITY HOSPITAL
OKAYAMA UNIVERSITY HOSPITAL
KURUME UNIVERSITY HOSPITAL
Name of secondary funder(s) ZENYAKU KOGYO CO.,LTD.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 04 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 03 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027938

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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