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

Primary Purpose

Polymyalgia Rheumatica

Status
Recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
SPI-62
SPI-62 matched placebo
Prednisolone 10mg
Additional prednisolone
Additional prednisolone matched placebo
Sponsored by
Sparrow Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring polymyalgia rheumatica, PMR, Steroids, Prednisolone, glucocorticoid, glucocorticoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische ImmunologieRecruiting
  • Internistische Praxisgemeinschaft Rheumatologie . NephrologieRecruiting
  • Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und AutoimmunmedizinRecruiting
  • Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-UniversitätRecruiting
  • Unikliniken KölnRecruiting
  • Prof. Dr. med. Herbert KellnerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SPI-62

SPI-62 + additional prednisolone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Erythrocyte sedimentation rate
C-reactive protein
Plasma fibrinogen

Secondary Outcome Measures

Full Information

First Posted
June 23, 2022
Last Updated
September 21, 2022
Sponsor
Sparrow Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05436652
Brief Title
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Official Title
A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sparrow Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyalgia Rheumatica
Keywords
polymyalgia rheumatica, PMR, Steroids, Prednisolone, glucocorticoid, glucocorticoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
Participant
Masking Description
Drug and Placebo are masked and assigned via Interactive Response Technology (IRT)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPI-62
Arm Type
Experimental
Arm Description
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.
Arm Title
SPI-62 + additional prednisolone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SPI-62
Intervention Description
11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor
Intervention Type
Drug
Intervention Name(s)
SPI-62 matched placebo
Intervention Description
Inactive tablets identical in appearance to SPI-62 tablets
Intervention Type
Drug
Intervention Name(s)
Prednisolone 10mg
Intervention Description
Standard of care prednisolone
Intervention Type
Drug
Intervention Name(s)
Additional prednisolone
Intervention Description
Over encapsulated prednisolone
Intervention Type
Drug
Intervention Name(s)
Additional prednisolone matched placebo
Intervention Description
Inactive capsules identical in appearance to over encapsulated prednisolone
Primary Outcome Measure Information:
Title
Erythrocyte sedimentation rate
Time Frame
Baseline to Day 28
Title
C-reactive protein
Time Frame
Baseline to Day 28
Title
Plasma fibrinogen
Time Frame
Baseline to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Katz
Phone
+1-617-465-0328
Email
david@sparrowpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Czerwiec, MD
Phone
16174650328
Email
fczerwiec@sparrowpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Katz
Organizational Affiliation
Sparrow Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Buttgereit, Prof
Phone
0049 30 450 513 025
Email
jan.zernicke@charite.de
Facility Name
Internistische Praxisgemeinschaft Rheumatologie . Nephrologie
City
Erlangen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Schuch, MD
Phone
0049 (0)9131 890040
Email
florian.schuch@pgrn.de
Facility Name
Hamburger Rheuma Forschungszentrum II im MVZ für Rheumatologie und Autoimmunmedizin
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Everding, MD
Phone
+ 49 40 323 103
Ext
166
Email
everding@hotmail.de
Facility Name
Katholische Kliniken Rhein-Ruhr am Marien Hospital, Universitätsklinik der Ruhr-Universität
City
Herne
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioana Andreica, MD
Phone
0049 2325 592 707
Email
Ioana.andreica@elisabethgruppe.de
Facility Name
Unikliniken Köln
City
Köln
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kofler, MD
Phone
0221-478-42882
Email
david.kofler@uk-koeln.de
Facility Name
Prof. Dr. med. Herbert Kellner
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herbert Kellner, Prof
Phone
089 / 13 959-100
Email
gk@prof-dr-kellner.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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