A study to investigate whether application of SPI-62 necessitates an increase of the prednisolone dose to maintain the same efficacy of treatment of polymyalgia rheumatica

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 72

Inclusion Criteria

1. Able to understand the nature and scope of the trial.
2. Written informed consent given prior to any trial-related procedures.
3. At least 18 years old.
4. Diagnosis of polymyalgia rheumatica according to EULAR/ACR classification criteria.
5. Absence of PMR relapse based on symptoms.
6. Absence of PMR relapse based on acute phase markers
7. Daily oral prednisolone 10 mg dose that will have been stable for at least 1 week at the Baseline Visit and is expected to remain stable during the treatment period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Known hypersensitivity to prednisolone, SPI-62 or any of the excipients.
2. Systemic fungal infection.
3. Administration of any vaccine within 4 weeks prior to the Baseline Visit or during the trial.
4. Any relative contraindication for prednisolone of sufficient severity that the investigator considers that the subject should receive immediate additional treatment or not continue prednisolone.
5. Fulfills all criteria and clearly qualifies to use methotrexate according to national or EULAR/ACR guideline for treatment of PMR, unless the subject refuses to take methotrexate or has a contraindication to methotrexate.
6. A diagnosis or any clinical features of giant cell arteritis.
7. Any known autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
8. Use of medications other than oral prednisolone for treatment of PMR.
9. Use of other medications likely to interfere with trial assessments.
See Section 7 for lists of medications that are and are not allowed during the trial. Use of any other medication (prescription, OTC, or traditional) or supplement within 4 weeks of the Baseline Visit is allowed only if the medication and dose (or PRN use) are approved by the Medical Monitor or Sponsor, the dose has been stable for at least 4 weeks, and the dose is expected to remain stable for the duration of the trial.
10. History of clinically significant labile diabetes or hypertension during glucocorticoid therapy.
11. History or diagnosis of endogenous hypercortisolism.
12. Moderate or severe renal impairment.
Defined by an estimated glomerular filtration rate (2021 CKD-EPI creatinine equation) repeatedly < 60 mL/min/1.73m2.
13. Medically significant liver disease.
Including cirrhosis, chronic active hepatitis, chronic persistent hepatitis, or subjects with serum total bilirubin > 1.5 × ULN (unless previously diagnosed with benign Gilbert’s disease) or serum ALT or AST >3 × ULN.
14. Medically significant cardiovascular or ECG abnormalities.
This includes subjects with recent (< 1 year) myocardial infarction or stroke, orthostatic or vasovagal syncope, QT interval corrected (QTc) interval > 500 ms, uncorrected QT interval > 600 ms, or evidence of significant, life-threatening arrhythmia or bradycardia (heart rate < 45 bpm).
15. History of idiopathic thrombocytopenic purpura.
16. Recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, which is defined as:
Positive lab-based test (polymerase chain reaction or antigen test) for active infection within the past 4 weeks or hospitalization for coronavirus disease 2019 (COVID-19) within the past 6 months.
17. History of cancer within 3 years other than non-melanoma skin cancer or early-stage prostate cancer (not dependent on hormone-suppression therapy).
18. Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
19. Pregnant, lactating, or woman of child-bearing potential unwilling to adhere to highly effective contraceptive use or abstinence as defined in Appendix 5.
20. Man unwilling to adhere to highly effective contraceptive use or abstinence as defined in Appendix 5.
21. Participation in any clinical trial of an experimental drug within 5 half-lives or 1 month prior to informed consent (or 3 months for biologic and long-lasting experimental therapies), whichever is longer.
22. Receipt of blood products within 2 months prior to Screening.
23. Donation of blood from 3 months prior to

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To identify whether a prednisolone dose adjustment is necessary to provide equivalent efficacy when administered with SPI-62 in subjects with PMR and, if so, estimate the adjustment<br>;Secondary Objective: • To observe whether SPI-62 mitigates prednisolone toxicity in subjects with PMR and, if so, estimate the appropriate dose to administer in combination withprednisolone<br>• To characterize the pharmacological activity of SPI-62 in subjects with PMR<br>• To report the safety of SPI-62 in subjects with PMR treated with prednisolone;Primary end point(s): Fibrinogen, erythrocyte sedimentation ratio, C-reactive protein;Timepoint(s) of evaluation of this end point: 2 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): oral glucose tolerance test glucose area under the concentration-time curve, osteocalcin, urinary 11ß-hydroxysteroid dehydrogenase type 1 ratio ;Timepoint(s) of evaluation of this end point: 2 weeks of treatment

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