To assess the safety and efficacy of ABBV-154 versus placebo in subjects with PMR, who are dependent on treatment with glucocorticoids withdoses of at least 5 mg/day prednisone equivalent (glucocorticoindependent PMR).
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to flare, where flare is defined as follows:
• Presence of clinical signs and symptoms of PMR
AND
• Requirement to increase the glucocorticoid dose per investigator.
Clinical signs and symptoms of PMR are defined as shoulder and/or hip girdle
pain with inflammatory stiffness, neck pain with inflammatory stiffness, or new
or worsened limited range of motion of hips and/or shoulders that are not due
to other causes
Timepoint of evaluation: week 24
Secondary outcome
• Achievement of flare-free state up to Week 24
• Cumulative glucocorticoid dose by 24 weeks
• Change from Baseline in glucocorticoid dose at Week 24
Background summary
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip,
and neck pain and stiffness, in adults aged 50 years or older. This study
evaluates how safe and effective ABBV-154 is in participants with
glucocorticoid-dependent PMR. Adverse events and change in disease activity
will be assessed.
Study objective
To assess the safety and efficacy of ABBV-154 versus placebo in subjects with
PMR, who are dependent on treatment with glucocorticoids with
doses of at least 5 mg/day prednisone equivalent (glucocorticoindependent PMR).
Study design
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging
Intervention
The study is compromised of a 52 week double-blind, placebo-controlled period
and a follow-up visit 70 days after the last dose of the study drug. All
participants will receive a glucocorticoid taper along with the assigned dose
of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).
Study burden and risks
There may be higher treatment burden for participants in this trial compared to
their standard of care. Participants will attend regular visits during the
study at a hospital or clinic. The effect of the treatment will be checked by
medical assessments, blood tests, checking for side effects and completing
questionnaires.
Knollstrasse 50
Ludwigshafen 67061
DE
Knollstrasse 50
Ludwigshafen 67061
DE
Listed location countries
Age
Inclusion criteria
1. Adults at least 50 years of age with a clinical diagnosis of PMR and
fulfillment of the 2012 EULAR/ACR provisional classification criteria for PMR.
2. Following a confirmed diagnosis of PMR, subject must have shown a clinical
response to prednisone (or equivalent).
3. Subject must have had at least 2 episodes of unequivocal PMR flare while
attempting to taper prednisone, with the dose of prednisone (or equivalent) at
the time of flare >= 5 mg/day, prior to Baseline; the most recent flare must
have been within 24 weeks of Baseline. Unequivocal PMR flare is defined as
clinical signs and symptoms of PMR (shoulder and/or hip girdle pain with
inflammatory stiffness, neck pain with inflammatory stiffness, or new or
worsened limited range of motion of hips and/or shoulders) that resulted in an
increase in glucocorticoid dose.
4. Subject must be on a stable prednisone (or equivalent) dose of 5 to 15
mg/day for >= 2 weeks prior to Baseline. Subjects may be on up to 25 mg/day at
the Screening Visit provided that the subject is able to taper to 15 mg/day or
less, with a stable dose >= 2 weeks prior to Baseline.
5. Subject must be willing to follow the protocol-defined glucocorticoid
tapering regimen.
Exclusion criteria
1. Subject must have discontinued use of immunomodulators other than prednisone
(or equivalent) and hydroxychloroquine prior to Baseline.
2. Subjects requiring > 25 mg/day of prednisone to control confirmed PMR are
excluded
3. Subject must not exhibit clinical signs and symptoms of PMR (shoulder and/or
hip girdle pain with inflammatory stiffness, neck pain with inflammatory
stiffness, or new or worsened limited range of motion of hips and/or shoulders)
within 2 weeks of Baseline
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-00533-39-NL |
| ClinicalTrials.gov | NCT04972968 |
| CCMO | NL77653.028.21 |