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A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)

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ClinicalTrials.gov Identifier: NCT05436652
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
Sparrow Pharmaceuticals

Study Description
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Brief Summary:
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR.

Condition or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: SPI-62 Drug: SPI-62 matched placebo Drug: Prednisolone 10mg Drug: Additional prednisolone Drug: Additional prednisolone matched placebo Phase 2

Detailed Description:
This will be a single-blind, placebo-controlled phase 2 trial to compare prednisolone effects with and without SPI-62 in subjects with PMR. Up to 4 cohorts of 12 subjects could be recruited (12 to 48 subjects). Each subject who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a screening period up to 28 days (Day -28 to Day-1), a 4-week treatment period (Day 1 to Day 28) and a follow up Period (Day 29 to Day 56). During the 4-week treatment period for the first cohort, all subjects will receive prednisolone 10mg per day for 4-weeks plus SPI-62 for 2-weeks and matching placebo for 2-weeks. For cohorts 2 through 4, the dose of prednisolone co-administered with SPI-62 could be adjusted.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Masking Description: Drug and Placebo are masked and assigned via Interactive Response Technology (IRT)
Primary Purpose: Treatment
Official Title: A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Actual Study Start Date : July 22, 2022
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SPI-62
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
 Drug: SPI-62
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor

Drug: SPI-62 matched placebo
Inactive tablets identical in appearance to SPI-62 tablets

Drug: Prednisolone 10mg
Standard of care prednisolone
Experimental: SPI-62 + additional prednisolone
Active drug / placebo by mouth each morning for up to 4 weeks + standard of care 10mg prednisolone + additional prednisolone or placebo. Each participant will receive both placebo and active drug but will be blinded to the sequence of active drug and placebo.
 Drug: SPI-62
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor

Drug: SPI-62 matched placebo
Inactive tablets identical in appearance to SPI-62 tablets

Drug: Prednisolone 10mg
Standard of care prednisolone

Drug: Additional prednisolone
Over encapsulated prednisolone

Drug: Additional prednisolone matched placebo
Inactive capsules identical in appearance to over encapsulated prednisolone


Outcome Measures
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Primary Outcome Measures :
  1. Erythrocyte sedimentation rate [ Time Frame: Baseline to Day 28 ]
  2. C-reactive protein [ Time Frame: Baseline to Day 28 ]
  3. Plasma fibrinogen [ Time Frame: Baseline to Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Diagnosis of PMR according to EULAR/ACR classification criteria
  • Absence of PMR relapse based on symptoms and acute phase markers
  • Daily oral prednisolone 10mg 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

Exclusion Criteria:

  • Any contraindication for prednisolone administration.
  • A diagnosis or any clinical features of giant cell arteritis.
  • Any autoimmune disease (e.g., late-onset rheumatoid arthritis) other than PMR.
  • Use of medications for treatment of PMR within specified intervals prior to the Baseline Visit other than oral prednisolone.
  • Use of other medications likely to interfere with trial assessments.
  • History or diagnosis of endogenous hypercortisolism.
  • Any current or prior medical condition, medical or surgical therapies, or clinical trial participation expected to interfere with the conduct of the trial or the evaluation of its results.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436652


Contacts
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Contact: David Katz +1-617-465-0328 david@sparrowpharma.com
Contact: Frank Czerwiec, MD 16174650328 fczerwiec@sparrowpharma.com

Locations
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Germany
Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie Recruiting
Berlin, Germany
Contact: Frank Buttgereit, Prof    0049 30 450 513 025    jan.zernicke@charite.de   
Internistische Praxisgemeinschaft Rheumatologie . Nephrologie Recruiting
Erlangen, Germany
Contact: Florian Schuch, MD    0049 (0)9131 890040    florian.schuch@pgrn.de   
Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin Recruiting
Hamburg, Germany
Contact: Andrea Everding, MD    + 49 40 323 103 ext 166    everding@hotmail.de   
Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität Recruiting
Herne, Germany
Contact: Ioana Andreica, MD    0049 2325 592 707    Ioana.andreica@elisabethgruppe.de   
Unikliniken Köln Recruiting
Köln, Germany
Contact: David Kofler, MD    0221-478-42882    david.kofler@uk-koeln.de   
Prof. Dr. med. Herbert Kellner Recruiting
Munich, Germany
Contact: Herbert Kellner, Prof    089 / 13 959-100    gk@prof-dr-kellner.de   
Sponsors and Collaborators
Sparrow Pharmaceuticals
Investigators
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Study Chair: David Katz Sparrow Pharmaceuticals
More Information
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Responsible Party: Sparrow Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05436652    
Other Study ID Numbers: SPI-62-CL-2003
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sparrow Pharmaceuticals:
polymyalgia rheumatica
PMR
Steroids
 Prednisolone
glucocorticoid
glucocorticoids
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Rheumatic Diseases
Connective Tissue Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
 Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones