Please assess the completion status of the following clinical trial:

Trial Title: Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: SEQUENTIAL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: TRIPLE
- Phase: PHASE2
- Number of Arms: 4.0

Eligibility Criteria:
Inclusion Criteria:~Individuals who meet all of the following criteria are eligible for enrollment as study participants:~1. Participant must be able to understand and provide informed consent and be willing to comply with study procedures and follow up.~2. Are at least 18 years of age and not older than 70 years of age at screening.~3. Meet the ACR/EULAR Classification Criteria for IgG4-RD \[30, 31\].~4. Have active disease based at screening on an IgG4-RD RI ≥4, with disease manifestations in at least two organ systems.~5. May have newly-diagnosed or relapsing disease at screening. Relapsing disease is defined as IgG4-RD that has previously been in remission but is now active again.~6. May be on treatment or off treatment for IgG4-RD at the time of screening. If on treatment, must be willing to discontinue those other treatments before the baseline visit.~7. No history of severe allergic reactions to monoclonal antibodies.~8. Female participants of childbearing potential must have a negative pregnancy test upon study entry.~9. Female participants of childbearing potential and male participants with a partner of childbearing potential must agree to consistently and correctly use FDA approved highly effective methods of birth control for the entire duration of the study and 6 months after last elotuzumab infusion.~10. Immunization with one of the FDA authorized or licensed SARS-CoV-2 vaccines as per CDC recommendations at the time of informed consent is required for study entry. Vaccinations must have been completed at least 2 weeks prior to start of study therapy.~Exclusion Criteria:~Individuals who meet any of these criteria are not eligible for enrollment as study participants:~1. Presence of a condition other than IgG4-RD that (e.g., asthma) is likely to require systemic Glucocorticoids (GC) for disease control during the period of the trial.~2. Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin.)~3. The following lab values as indicators of hepatic dysfunction:~   1. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal (ULN)~  2. Total bilirubin \> two times the ULN unless caused by Gilbert's disease. Gilbert's disease with total bilirubin \> three times ULN.~  3. Serum albumin \< 2.5 gm/dL.~4. Evidence of another uncontrolled condition which, in the judgment of the investigator, could interfere with participation in the trial according to the protocol.~5. Active infection requiring hospitalization or treatment with systemic antimicrobial agents within the 30 days prior to treatment allocation/randomization.~6. Prior use of rituximab or other B cell depleting agents within 9 months of enrollment unless B cells have been demonstrated to have repopulated.~7. Use of any investigational agent or biologic and non-biologic DMARDs within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment.~8. Any of the following laboratory tests at the Screening Visit:~   1. White blood cell count (WBC) \< 3.0 x 103/µL.~  2. Absolute neutrophil count (ANC) \< 1.5 x 103/µL.~  3. Hemoglobin \< 10 g/dL.~  4. Platelet count \< 75 x 109/L.~  5. Estimated glomerular filtration rate (eGFR) ≤ 45 ml/minute/1.73 m2.~9. The use of supplemental oxygen at baseline.~10. At or within 90 days of screening: Positive Interferon-Gamma Release Assay (IGRA). Indeterminate IGRAs must be repeated (with same or other IGRA per local policy) and shown to be negative. Alternatively, if the assay remains indeterminant, a participant must have a negative PPD. Finally, if the participant has had the Bacille Calmette-Guerin (BCG) vaccine or has some other condition complicating the interpretation of TB testing, consultation with infectious disease specialist must be obtained before receipt of the first investigational infusion.~    a. Participants diagnosed with latent TB are eligible but must have received appropriate prophylaxis for 30 days before their first investigational infusion.~11. Medical history or serologic evidence at Screening of chronic infections including:~    1. Human immunodeficiency virus infection.~   2. Hepatitis B as indicated by surface antigen or hepatitis B core antibody positivity~   3. Hepatitis C as indicated by anti-hepatitis C antibody positivity; if a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he/she is negative for viral load at Screening.~12. Live vaccines within 8 weeks of initiating study therapy.~13. Participant is pregnant or breastfeeding, or planning a pregnancy while enrolled in the study.~14. Substance use disorder, including the recurrent use of alcohol and/or drugs within the past year associated with clinically significant impairment associated with failure to meet major responsibilities at work, school, or home.~15. IgG4-RD that is dominated primarily by advanced fibrotic lesions. Specifically, participants whose disease manifestations consist only of~    1. retroperitoneal fibrosis,~   2. fibrosing mediatinitis,~   3. sclerosing mesenteritis, or~   4. Riedel's thyroiditis. Participants with these disease manifestations can be included, however, only if they have disease in 2 organ systems that is not of an advanced fibrotic nature and otherwise meet the Inclusion and Exclusion Criteria.~16. Evidence a SARS-CoV-2 (COVID-19) infection started within the 30 days prior to treatment allocation/randomization. Participants diagnosed with SARS-CoV-2 (COVID-19) infection more than 30 days prior to treatment allocation/randomization must have symptoms resolved and be deemed fit to participate in the trial.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 70 Years
- Healthy Volunteers: f

Study Arms:
- Cohort 1a: Elotuzumab-One-Month Regimen (Open-Label) + Pred Taper (Type: EXPERIMENTAL): Per protocol: Six participants will receive elotuzumab on days 0,7, 14, 21, and the prescribed 10-week prednisone taper.~* Elotuzumab: 10 mg/kg administered once weekly, intravenously for 4 doses, per protocol.~* Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 (baseline) that is taken orally (by mouth) daily, per protocol. Dosage in milligrams (mgs).
- Cohort 1b: Elotuzumab-Twelve-Month Regimen (Open-Label) + Pred Taper (Type: EXPERIMENTAL): Per protocol: Six participants will receive elotuzumab over a 48 week period, dose of 10mg/kg IV x 1, at baseline, then at weeks 8, 16, 24, 32 and 40 (for a total of 6 doses), with the prescribed 10-week prednisone taper.~* Elotuzumab: 10 mg/kg administered as referenced above, intravenously, per protocol.~* Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 (baseline) that is taken orally (by mouth) daily, per protocol. Dosage in milligrams (mgs).
- Cohort 2: Arm A- Elotuzumab (Randomized) + Pred Taper (Type: EXPERIMENTAL): Safety and efficacy analyses from Cohort 1a and Cohort 1b will occur prior to initiating Cohort 2 (Randomized).~Assuming no safety signal for Cohort 1, forty-two participants will receive elotuzumab per the regimen prescribed above in Part 1B, with the prescribed 10-week prednisone taper.~* Elotuzumab: 10 mg/kg administered as referenced above, intravenously, per protocol.~* Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 that is taken daily by mouth, per protocol. Dosage in milligrams (mgs).
- Cohort 2: Arm B-Placebo (Randomized) + Pred Taper (Type: PLACEBO_COMPARATOR): Safety and efficacy analyses from Cohort 1a and Cohort 1b will occur prior to initiating Cohort 2 (Randomized).~Twenty-one participants will receive placebo for elotuzumab on day 0, then weeks 8, 16, 24, 32 and 40, and the prescribed 10-week prednisone taper.~* Placebo for elotuzumab: Administered on same schedule as elotuzumab described in Cohort 2 Arm A: intravenously, per protocol.~* Prednisone taper (Pred Taper): Prescribed 10-week dosing taper beginning on Day 0 taken daily by mouth, per protocol. Dosage in milligrams (mgs).

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy