A Phase 1 interventional study of Prednisolone and SPI-62 in Polymyalgia Rheumatica, sponsored by Sparrow Pharmaceuticals. Terminated at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Sparrow Pharmaceuticals · Phase 1, Interventional, and Treatment
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
This will be an open label phase 1b trial to characterize the pharmacodynamics and PK of prednisolone and SPI-62 when co-administered to participants with PMR. Up to 24 participants could be recruited.
Patients diagnosed with PMR whose PMR symptoms do not vary in intensity or frequency to the degree that a clinically indicated increase in prednisolone prescription might be anticipated will be included in the trial.
Participants will continue to receive prednisolone and will receive SPI-62 from Days 3-16
Inflammatory biomarkers, symptom measures, biomarkers of prednisolone toxicity, PK of prednisolone and SPI-62, and biomarkers of SPI-62 pharmacological activity will be measured on Days 2, 3, and 16. ABPM will be monitored on days 1 and 15.
68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.
This study's enrollment of 1 is below the median of 66 across 39 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →Sparrow Pharmaceuticals is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive prednisolone throughout the trial and SPI-62 on days 3-16.
Drug: Prednisolone · Drug: SPI-62
Prednisolone according to the participant's pre-trial dose, symptoms and inflammatory biomarkers.
SPI-62 administered once daily.
Erythrocyte sedimentation rate
Time frame: Baseline to Day 28
C-reactive protein
Time frame: Baseline to Day 28
Plasma fibrinogen
Time frame: Baseline to Day 28
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Mar 2025, 37 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ASP3662
Sparrow Pharmaceuticals