Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)
- Conditions
- IgG4-Related DiseaseMedDRA version: 20.0Level: LLTClassification code 10071581Term: IgG4 related sclerosing diseaseSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-002214-31-GB
- Lead Sponsor
- Xencor, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
1. Male or female 12 years of age or older
2. Able to provide written informed consent. For subjects 12 to 18 years of age, the adolescent signs a patient assent form, and the parent or the legal guardian must sign the ICF.
3. Meet the ACR/EULAR classification criteria for IgG4-RD with a score of = 20
4. Must have active IgG4-RD signs/symptoms that require, as assessed by the Investigator, the initiation of corticosteroid therapy or the increase in background long-term corticosteroid therapy (if previously on a stable dose of = 10 mg/day prednisone equivalent).
5. An oral corticosteroid dose must be maintained at a stable dose for 14 to 28 days during the 28-day screening period prior to randomization.
6. Must be able and willing to receive corticosteroid therapy during the induction phase of the trial and be able to taper off any systemic corticosteroid therapy per protocol
7. Must be willing to stop other IgG4-RD directed medications during screening (eg. methotrexate, mycophenolate mofetil, 6-mercaptopurine or azathioprine).
8. Must have a negative serum pregnancy test within 14 days before randomization.
9. Female subjects of childbearing potential must agree to use a highly effective method of birth control from screening until 8 weeks after the last dose of XmAb5871/placebo is given. Women are considered to be of childbearing potential unless it is documented that they are premenarche OR postmenopausal by history with no menses for 1 year and confirmed by follicle stimulating hormone (FSH) OR have a history of hysterectomy and/or bilateral oophorectomy and/or bilateral
salpingectomy. Highly effective methods of birth control include combined hormonal birth control (oral, intravaginal, transdermal) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, intrauterine), intrauterine devices (IUDs), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner (provided partner is the sole sexual partner and there has been a medical assessment of surgical success), or sexual
abstinence (when this is in line with the preferred and usual lifestyle of the subject). Sexual counseling of adolescent study subjects should take place prior to entrance into the study.
10. No history of severe allergic reactions to monoclonal antibodies.
11. Are able and willing to complete the entire study according to the study schedule.
12. Are willing to forego other forms of experimental treatment during the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 143
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95
1. Any Exclusion Criteria as listed in the ACR/EULAR IgG4-RD Classification Criteria (see Appendix 1 of Protocol)
2. Initiation of corticosteroid therapy (or increase in long-term corticosteroid therapy) for new or exacerbated signs/symptoms of IgG4-RD > 14 days before enrolment
3. Corticosteroid dose has exceeded 60 mg/day prednisone equivalent given orally within 14 days prior to screening or will exceed 60 mg/day during the screening .period.
4. Corticosteroids have been given by the IV or IM route within 14 days prior to screening or will be given by these routes of administration during the screening period.
5. IgG4-RD requiring long-standing corticosteroid therapy at a dose of > 10 mg/day prednisone equivalent
6. Subjects with disease in only 1 organ system whose primary manifestation is fibrosis (for example, neuro-meningeal involvement, retroperitoneal fibrosis, fibrosing or sclerosing mesenteritis) will be excluded.
7. History or evidence of a clinically unstable/uncontrolled disorder, condition or disease (including but not limited to cardiopulmonary, oncologic, renal, hepatic, metabolic, hematologic or psychiatric) other than IgG4-RD that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
8. Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, breast cancer with no recurrence = 5 years following therapy, or prostate cancer with no recurrence =3 years following prostatectomy).
9. Presence of recurrent or chronic infections, defined as =3 infections requiring antimicrobials over the past 6 months prior to screening.
10. Active infection requiring hospitalization or treatment with parenteral antimicrobials within the 30 days prior to randomization or oral antimicrobials within the 14 days prior to randomization.
11. Prior use of rituximab (or other B cell depleting agents) within 5 months of randomization.
12. Use of any investigational agent within 5 half-lives of the agent (or 3 months if the half-life is unknown) prior to randomization.
13. White blood cell count < 2.5 x 103/µL.
14. Absolute neutrophil count (ANC) < 1.0 x 103/µL.
15. Elevated serum creatinine > 2.5 x upper limit of normal (ULN) OR estimated creatinine clearance < 40 mL/minutes calculated by the Cockroft-Gault formula at screening.
16. Hemoglobin < 10 g/dL.
17. Platelet count < 75 x 109/L.
18. Positive test result for human immunodeficiency virus (HIV) I and II antibody, hepatitis B surface antigen, (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (HCV Ab).
19. Has received live vaccines within 4 weeks before randomization.
20. Inability to communicate reliably with the Investigator.
21. Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study.
22. Positive pregnancy test at screening or at any time during the study.
23. Subjects who do not agree to use medically acceptable methods of contraception.
24. Known or suspected sensitivity to mammalian cell-derived products or any components of the study drug.
25. Unable or unwilling to partake in follow-up assessments or required protocol procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method