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

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

Study Overview

• Status: Recruiting
• Conditions: Polymyalgia Rheumatica
• Intervention / Treatment: Drug: SPI-62; Drug: SPI-62 matched placebo; Drug: Prednisolone 10mg; Drug: Additional prednisolone; Drug: Additional prednisolone matched placebo

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: David Katz; Phone Number: +1-617-465-0328; Email: david@sparrowpharma.com
• Study Contact Backup: Name: Frank Czerwiec, MD; Phone Number: 16174650328; Email: fczerwiec@sparrowpharma.com

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
    • Contact: Frank Buttgereit, Prof; Phone Number: 0049 30 450 513 025; Email: jan.zernicke@charite.de
  • Erlangen, Germany
    • Recruiting
    • Internistische Praxisgemeinschaft Rheumatologie . Nephrologie
    • Contact: Florian Schuch, MD; Phone Number: 0049 (0)9131 890040; Email: florian.schuch@pgrn.de
  • Hamburg, Germany
    • Recruiting
    • Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin
    • Contact: Andrea Everding, MD; Phone Number: 166 + 49 40 323 103; Email: everding@hotmail.de
  • Herne, Germany
    • Recruiting
    • Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität
    • Contact: Ioana Andreica, MD; Phone Number: 0049 2325 592 707; Email: Ioana.andreica@elisabethgruppe.de
  • Köln, Germany
    • Recruiting
    • Unikliniken Köln
    • Contact: David Kofler, MD; Phone Number: 0221-478-42882; Email: david.kofler@uk-koeln.de
  • Munich, Germany
    • Recruiting
    • Prof. Dr. med. Herbert Kellner
    • Contact: Herbert Kellner, Prof; Phone Number: 089 / 13 959-100; Email: gk@prof-dr-kellner.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Erythrocyte sedimentation rate	Baseline to Day 28
C-reactive protein	Baseline to Day 28
Plasma fibrinogen	Baseline to Day 28

Collaborators and Investigators

• Sponsor: Sparrow Pharmaceuticals
• Investigators: Study Chair: David Katz, Sparrow Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Prednisolone; Steroids; glucocorticoid; glucocorticoids; polymyalgia rheumatica; PMR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Arteritis; Polymyalgia Rheumatica; Giant Cell Arteritis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: SPI-62-CL-2003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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