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NCT02383589 · CITED IN SOURCE DOCUMENTS

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-11-10

This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening. Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness. The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score

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outcome · POSTED

Cumulative Oral Corticosteroid Dose

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outcome · POSTED

Total Number of Protocol Defined Disease Flares

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outcome · POSTED

Time to Initial Sustained Complete Remission

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outcome · POSTED

Time to Protocol Defined Disease Flare

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outcome · POSTED

Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score

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outcome · POSTED

Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events

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outcome · POSTED

Percentage of Participants With Anti-Drug Antibodies (ADA)

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outcome · POSTED

Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of PV within the previous 24 months, based on the presence of histological features of acantholysis via skin or mucosal biopsy and one of the following: tissue bound immunoglobulin G (IgG) antibodies by direct immunofluorescence on the surface of affected epithelium or serological detection of serum desmoglein-3 (DSg3) autoantibodies against epithelial cell surface either by indirect immunofluorescence microscopy or by enzyme-linked immunosorbent assay * Presence of moderate-to-severely active disease, defined as overall PDAI activity score of greater than or equal to (\>/=)15 * Receiving standard-of-care corticosteroids consisting of 60-120 mg/day oral prednisone or equivalent and, in the judgment of the investigator, expected to benefit from the addition of immunosuppressive therapy * For women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two effective methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 12 months after the last dose of study treatment Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception Barrier methods must always be supplemented with the use of a spermicide Examples of contraceptive methods with a failure rate of \< 1% per year (highly effective contraceptive methods) include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices * For men (including those who have undergone a vasectomy): agreement to remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of study treatment and agreement to refrain from donating sperm during this same period Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the participant Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. In addition to male contraception, agreement to advise female partners of childbearing potential to use highly effective contraception during the study and for at least 12 months after the last dose of study treatment * Agreement to avoid excessive exposure to sunlight during study participation * Able to comply with the study protocol, in the investigator's judgment Exclusion Criteria: * Diagnosis of pemphigus foliaceus or evidence of paraneoplastic pemphigus or other non-PV autoimmune blistering disease * History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies, or known hypersensitivity to any component of rituximab * Known hypersensitivity or contraindication to MMF, mycophenolic acid, polysorbate, or oral corticosteroids * Lack of peripheral venous access * Pregnant or lactating, or intending to become pregnant during the study Women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have two negative results with a sensitivity of \>/=25 milli-international units per milliliter (mIU/mL): one from a serum pregnancy test at Day -8 to Day -10 of screening and another from a urine pregnancy test at Day 1 prior to randomization * Participated in another interventional clinical trial within 28 days prior to randomization * Use of any investigational agent within 28 days or 5 elimination half-lives prior to randomization (whichever is the longer) * Significant cardiovascular or pulmonary disease (including obstructive pulmonary disease) * Evidence of any new or uncontrolled concomitant disease that, in the investigator's judgment, would preclude participant participation, including but not limited to nervous system, renal, hepatic, endocrine, malignant, or gastrointestinal disorders * Any concomitant condition that required treatment with oral or systemic corticosteroids within 12 weeks prior to randomization * Treatment with intravenous (IV) immunoglobulin (Ig), plasmapheresis, or other similar procedure within 8 weeks prior to randomization * Treatment with immunosuppressive medications (e.g., azathioprine, MMF) within 1 week prior to randomization * Treatment with cyclophosphamide within 12 weeks prior to randomization * History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe immunodeficiency blood disorders * Known active infection of any kind (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization; entry into this study may be reconsidered once the infection has fully resolved * History of or current cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except complete excision of basal cell of the skin and squamous cell carcinoma of the skin that have been treated or excised and cured) * Currently active alcohol or drug abuse, or history of alcohol or drug abuse within 24 weeks prior to screening * Major surgery within 4 weeks prior to randomization, excluding diagnostic surgery * Treatment with rituximab or a B cell-targeted therapy (e.g., anti-cluster of differentiation \[CD\] 20 \[CD20\], anti CD22, or anti-B-lymphocyte stimulator \[BLyS\]) within 12 months prior to randomization * Treatment with a live or attenuated vaccine within 28 days prior to randomization; it is recommended that a participant's vaccination record and the need for immunization prior to study entry be carefully investigated * Evidence of abnormal liver enzymes or hematology laboratory values * Positive test results for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) serology at screening
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive MMF orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants will also receive rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria have been met.
    intervention Names
    1. Drug: Mycophenolate Mofetil
    2. Drug: Rituximab Placebo
    label
    Mycophenolate Mofetil (MMF)
    type
    ACTIVE_COMPARATOR
  2. description
    Participants will receive rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria have been met. Participants will also receive MMF matching placebo orally twice daily Q12H from Day 1 to Week 52.
    intervention Names
    1. Drug: Mycophenolate Mofetil Placebo
    2. Drug: Rituximab
    label
    Rituximab (RTX)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Rituximab (RTX)
    description
    MMF matching placebo will be administered orally Q12H.
    name
    Mycophenolate Mofetil Placebo
    type
    DRUG
  2. arm Group Labels
    1. Mycophenolate Mofetil (MMF)
    description
    MMF will be administered at a starting dose of 500 milligrams (mg) Q12H and the dose will be titrated to achieve a goal of 1 gram (gm) Q12H.
    name
    Mycophenolate Mofetil
    other Names
    1. MMF, CellCept
    type
    DRUG
  3. arm Group Labels
    1. Rituximab (RTX)
    description
    Rituximab will be administered at a dose of 1000 mg via IV infusion.
    name
    Rituximab
    other Names
    1. MabThera/Rituxan
    type
    DRUG
  4. arm Group Labels
    1. Mycophenolate Mofetil (MMF)
    description
    Rituximab matching placebo will be administered via IV infusion.
    name
    Rituximab Placebo
    other Names
    1. MabThera/Rituxan
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
135
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score
    time Frame
    From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018)
secondary Outcomes
  1. measure
    Cumulative Oral Corticosteroid Dose
    time Frame
    From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
  2. description
    Disease flare is defined as appearance of three or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who has achieved disease control.
    measure
    Total Number of Protocol Defined Disease Flares
    time Frame
    From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
  3. measure
    Time to Initial Sustained Complete Remission
    time Frame
    From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
  4. description
    Disease flare is defined as the appearance of three or more new lesions a month that do not heal spontaneously within 1 week or by the extension of established lesions in a participant who has achieved disease control.
    measure
    Time to Protocol Defined Disease Flare
    time Frame
    From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
  5. description
    Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.
    measure
    Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score
    time Frame
    From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
  6. description
    An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator.
    measure
    Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events
    time Frame
    Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
  7. description
    Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear.
    measure
    Percentage of Participants With Anti-Drug Antibodies (ADA)
    time Frame
    Baseline up to 52 Weeks (up to CCOD of 28 November 2018)
  8. measure
    Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)
    time Frame
    Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018)
Full study description
brief Summary
This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening. Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness. The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.
Source references
references
  1. citation
    Werth VP, Joly P, Mimouni D, Maverakis E, Caux F, Lehane P, Gearhart L, Kapre A, Pordeli P, Chen DM; PEMPHIX Study Group. Rituximab versus Mycophenolate Mofetil in Patients with Pemphigus Vulgaris. N Engl J Med. 2021 Jun 17;384(24):2295-2305. doi: 10.1056/NEJMoa2028564. Epub 2021 May 19.
    pmid
    34097368
    type
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Source notices and limitations
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      source file sha256
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      payload sha256
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      clinical indication matching status
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      link basis
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      nct id
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      occurrences
      1. context exact
        taphylococcal sepsis) and 1 patient (3%) in the prednisone group experienced 1 serious infection ( Pneumocystis jirovecii pneumonia). PV Study 2 In PV Study 2 (NCT02383589), a randomized, double-blind, double-dummy, active-comparator, multicenter study evaluating the efficacy and safety of RITUXAN compared to mycophenolate mofeti
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        exact text
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      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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      source url
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      spl effective time
      20250106
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      requested nct id
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      primary nct id
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      source kind
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      source url
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. BLA761103
      clinical indication matching status
      not_inferred
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      true
      id
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      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
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      occurrences
      1. context exact
        N=46 Prednisone N=44 Number of responders (response rate [%]) 41 (89%) 15 (34%) PV patients 34/38 (90%) 10/36 (28%) PF patients 7/8 (88%) 5/8 (63%) PV Study 2 (NCT02383589) In a randomized, double-blind, double-dummy, active-comparator, multicenter study, the efficacy and safety of rituximab compared to mycophenolate mofetil (MMF
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        exact text
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      source json pointer
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      source kind
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      source string basis
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      source string sha256
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      source url
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      spl effective time
      20260826
      spl set id
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    5. release id
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      requested nct id
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      primary nct id
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      source kind
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      source url
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      source record id
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. BLA761088
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-749f0bee275d2fbc4435
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
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      occurrences
      1. context exact
        aphylococcal sepsis) and 1 patient (3%) in the prednisone group experienced 1 serious infection ( Pneumocystis jirovecii pneumonia). PV Study 2 In PV Study 2 ( NCT02383589 ), a randomized, double-blind, double-dummy, active-comparator, multicenter study evaluating the efficacy and safety of rituximab compared to mycophenolate mof
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        exact text
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      source file sha256
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      source json pointer
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      source kind
      fda_spl_label
      source record id
      a284d45e-6142-4bfa-b716-7f2b976ffb0b
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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      source url
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      spl effective time
      20260713
      spl set id
      9af3ddc7-4217-417a-ac89-8704edc5bc44
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      edge id
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      requested nct id
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      primary nct id
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      source kind
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      source url
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. BLA761140
      clinical indication matching status
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      nct-edge-af73f923febd2877a5b9
      link basis
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      nct id
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      occurrences
      1. context exact
        Staphylococcal sepsis) and 1 patient (3%) in the prednisone group experienced 1 serious infection (Pneumocystis jirovecii pneumonia). PV Study 2 In PV Study 2 (NCT02383589), a randomized, double-blind, double-dummy, active-comparator, multicenter study evaluating the efficacy and safety of rituximab compared to mycophenolate mofe
        end
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        exact text
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      source file sha256
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      source json pointer
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      source kind
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      source string basis
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      source string sha256
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      source url
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      spl effective time
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      source kind
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      source url
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      source record id
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. BLA761103
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-be9a2ae4b330df693afc
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
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      occurrences
      1. context exact
        taphylococcal sepsis) and 1 patient (3%) in the prednisone group experienced 1 serious infection ( Pneumocystis jirovecii pneumonia). PV Study 2 In PV Study 2 (NCT02383589), a randomized, double-blind, double-dummy, active-comparator, multicenter study evaluating the efficacy and safety of rituximab compared to mycophenolate mofe
        end
        31911
        exact text
        NCT02383589
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      offset unit
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      source file
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      source file sha256
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      source json pointer
      /results/7/adverse_reactions/0
      source kind
      fda_spl_label
      source record id
      1f47d28b-1604-4e95-a668-46d81e4b5b27
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      ad434821b48db0bd93218601caff40ceedf4d8394d6209f92767ee70d6884b9e
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=100&sort=id%3Aasc
      spl effective time
      20260826
      spl set id
      f941fc61-f7a3-4e4a-ab7c-87c1667fa05b
    8. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
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      requested nct id
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      primary nct id
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      source kind
      fda_spl_label
      source url
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      source record id
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      source file sha256
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      payload sha256
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      payload
      application numbers
      1. BLA761140
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-e06845b7bea035495f48
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
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      occurrences
      1. context exact
        46 Prednisone N = 44 Number of responders (response rate [%]) 41 (89%) 15 (34%) PV patients 34/38 (90%) 10/36 (28%) PF patients 7/8 (88%) 5/8 (63%) PV Study 2 (NCT02383589) In a randomized, double-blind, double-dummy, active-comparator, multicenter study, the efficacy and safety of rituximab compared to mycophenolate mofetil (MMF
        end
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        exact text
        NCT02383589
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      offset unit
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      source file
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      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
      957e4262742ed080345b74d0edb345da59018647f4bbcda88c6659911ae5da1a
      source url
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      spl effective time
      20260722
      spl set id
      da1c4de7-0e5b-4f72-97ec-7a8d368f085f

    Preserved source evidence · Not medical advice