Phase 2 Polymyalgia Rheumatica Trial, Terminated NCT04972968 Sponsor: AbbVie Condition: Polymyalgia Rheumatica
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT04972968) enrolled 181 adults in total across four groups: 50 received a placebo (a dummy injection), and 42, 45, and 44 received different doses of an investigational medicine called ABBV-154 (40 mg, 150 mg, and 340 mg, given as an injection under the skin). The trial was looking at polymyalgia rheumatica (PMR), a condition causing muscle pain and stiffness, and was mainly measuring how long it took before participants experienced a "flare" — meaning their symptoms returned and their doctor needed to increase their steroid dose. It is worth noting that relatively few participants completed the full study period: 12 in the placebo group and 7–8 in each ABBV-154 group. The reported data shows that the main outcome — time to flare — was 113 days on average for the placebo group and 225 days for the lowest dose (40 mg) group. For the two higher doses (150 mg and 340 mg), a time-to-flare figure was not reported in the submitted data, which may indicate that not enough flare events occurred in those groups to calculate a meaningful average. For the secondary outcomes, the percentage of participants who remained flare-free throughout the study was reported as 11% (placebo), 13% (40 mg), 15% (150 mg), and 24% (340 mg). The reported data also shows the total steroid dose taken over the study was 984.6 mg for the placebo group, compared with 823.4 mg, 734.3 mg, and 759.5 mg for the three ABBV-154 doses respectively. The reported change in steroid dose from the start of the study was a reduction of approximately 5.0 mg for placebo, and reductions of 6.3 mg, 7.4 mg, and 7.9 mg for the three ABBV-154 doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Polymyalgia Rheumatica Trial, Terminated

NCT04972968
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a condition called Polymyalgia Rheumatica (PMR) and meet a specific set of recognised criteria used to confirm this diagnosis.
  • You have had at least 2 clear episodes where your PMR symptoms have flared up (come back or gotten worse).
  • You are currently taking a steady, unchanged dose of the steroid medication prednisone.
  • You are willing to follow a planned schedule for gradually reducing your prednisone dose as set out by the trial.

Who may not be able to join:

  • You have previously been treated with a type of medication called a TNF antagonist (a specific kind of drug that affects the immune system — confirm with trial site if unsure whether this applies to you).
  • You are currently taking any medicines that affect the immune system, apart from prednisone or hydroxychloroquine.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: ABBVIE INC., AbbVie

Australian sites

Emeritus Research Sydney /ID# 229166, Botany, New South Wales
Royal Prince Alfred Hospital /ID# 244888, Camperdown, New South Wales
BJC Health /ID# 244839, Parramatta, New South Wales
Tasman Health Care /ID# 230829, Southport, Queensland
The Queen Elizabeth Hospital /ID# 229049, Woodville South, South Australia
Emeritus Research /ID# 229270, Camberwell, Victoria
Austin Health /ID# 229164, Heidelberg, Victoria
Fiona Stanley Hospital /ID# 229050, Murdoch, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
9 September 2021
Est. completion
24 July 2023

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Time to Flare

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Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov