Trial · NCT04972968

A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154

NCT04972968, Phase 2, Terminated, AbbVie; results first posted 2024-10-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154. Trials, record NCT04972968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04972968

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
NCT number: NCT04972968
Status: Terminated
Phases: Phase 2
Enrollment: 181 participants, actual
Lead sponsor: AbbVie
Conditions: Polymyalgia Rheumatica
Interventions: ABBV-154, Placebo, Glucocorticoid
First posted: 2021-07-22
Last updated: 2024-10-15
Other registries' IDs: eudract:2021-000648-23
Results first posted: 2024-10-15
Limitations and caveats: AbbVie has decided to discontinue further subject enrollment in the M20-370 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Flare	From first dose of study drug to Week 52	Flare is defined as, presence of clinical signs and symptoms of PMR and requirement to increase the glucocorticoid dose per investigator.
Secondary	Percentage of Participants Achieving Flare-Free State	Up to Week 24	Percentage of participants achieving flare-free state.
Secondary	Cumulative Glucocorticoid Dose	Week 24	Cumulative glucocorticoid dose.
Secondary	Change From Baseline in Glucocorticoid Dose	Week 24	Change from Baseline in glucocorticoid dose.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Flare	From first dose of study drug to Week 52	ITT Population	days	MEDIAN
SECONDARY	Percentage of Participants Achieving Flare-Free State	Up to Week 24	ITT Population with data available for analysis	percentage of participants	NUMBER
SECONDARY	Cumulative Glucocorticoid Dose	Week 24	ITT Population with data available for analysis	Glucocorticoid dose (mg)	MEAN
SECONDARY	Change From Baseline in Glucocorticoid Dose	Week 24	ITT Population with data available for analysis	mg	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to Flare	Placebo	113	95% Confidence Interval 84 to 141	days
Time to Flare	ABBV-154, 40mg SC	225	95% Confidence Interval 140 to NA	days
Time to Flare	ABBV-154, 150mg SC	NA	95% Confidence Interval 141 to NA	days
Time to Flare	ABBV-154, 340mg SC	NA	95% Confidence Interval NA to NA	days
Percentage of Participants Achieving Flare-Free State	Placebo	11		percentage of participants
Percentage of Participants Achieving Flare-Free State	ABBV-154 40mg SC	13		percentage of participants
Percentage of Participants Achieving Flare-Free State	ABBV-154 150mg SC	15		percentage of participants
Percentage of Participants Achieving Flare-Free State	ABBV-154 340mg SC	24		percentage of participants
Cumulative Glucocorticoid Dose	Placebo	984.576	Standard Deviation 524.6579	Glucocorticoid dose (mg)
Cumulative Glucocorticoid Dose	ABBV-154 40mg SC	823.411	Standard Deviation 397.9403	Glucocorticoid dose (mg)

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	50
Overall Study	STARTED	ABBV-154, 40mg SC	42
Overall Study	STARTED	ABBV-154, 150mg SC	45
Overall Study	STARTED	ABBV-154, 340mg SC	44
Overall Study	COMPLETED	Placebo	12
Overall Study	COMPLETED	ABBV-154, 40mg SC	8
Overall Study	COMPLETED	ABBV-154, 150mg SC	8
Overall Study	COMPLETED	ABBV-154, 340mg SC	7
Overall Study	NOT COMPLETED	Placebo	38
Overall Study	NOT COMPLETED	ABBV-154, 40mg SC	34

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events220

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	NEUTROPENIA	Blood and lymphatic system disorders	Placebo	0	50	0
other	NEUTROPENIA	Blood and lymphatic system disorders	ABBV-154 40mg SC	0	42	0
other	NEUTROPENIA	Blood and lymphatic system disorders	ABBV-154 150mg SC	3	45	4
other	NEUTROPENIA	Blood and lymphatic system disorders	ABBV-154 340mg SC	0	44	0
other	DIARRHOEA	Gastrointestinal disorders	Placebo	4	50	4
other	DIARRHOEA	Gastrointestinal disorders	ABBV-154 40mg SC	2	42	3
other	DIARRHOEA	Gastrointestinal disorders	ABBV-154 150mg SC	2	45	2
other	DIARRHOEA	Gastrointestinal disorders	ABBV-154 340mg SC	3	44	4
other	NAUSEA	Gastrointestinal disorders	Placebo	2	50	3
other	NAUSEA	Gastrointestinal disorders	ABBV-154 40mg SC	3	42	3

1 to 10 of 220Source ClinicalTrials.gov

See all 220 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	50
Total, all-cause mortality	ABBV-154 40mg SC	0	42
Total, all-cause mortality	ABBV-154 150mg SC	0	45
Total, all-cause mortality	ABBV-154 340mg SC	0	44
Total, other adverse events	Placebo	27	50
Total, other adverse events	ABBV-154 40mg SC	25	42
Total, other adverse events	ABBV-154 150mg SC	30	45
Total, other adverse events	ABBV-154 340mg SC	37	44
Total, serious adverse events	Placebo	8	50
Total, serious adverse events	ABBV-154 40mg SC	5	42

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04972968

GET https://conductscience.org/api/trials/v1/NCT04972968/events?page=2

API reference For AI assistants