A Study to Evaluate the Safety and Efficacy (How Well the Study Treatment Works) of ABBV-2294 in Adult Participants With Systemic Sclerosis That Are Currently Receiving Local Standard of Care Treatment, and to Determine the Best Dose of ABBV-2294 to be Evaluated Further.

NCT07933211, Phase 2, Phase 3, Not yet recruiting, AbbVie

Trial 10

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

Field	Value	Source
Title	A Study to Evaluate the Safety and Efficacy (How Well the Study Treatment Works) of ABBV-2294 in Adult Participants With Systemic Sclerosis That Are Currently Receiving Local Standard of Care Treatment, and to Determine the Best Dose of ABBV-2294 to be Evaluated Further.	ClinicalTrials.gov
NCT number	NCT07933211	ClinicalTrials.gov
Status	Not yet recruiting	ClinicalTrials.gov
Phases	Phase 2, Phase 3	ClinicalTrials.gov
Enrollment	580 participants, estimated	ClinicalTrials.gov
Lead sponsor	AbbVie	ClinicalTrials.gov
Conditions	Systemic Sclerosis	ClinicalTrials.gov
Interventions	ABBV-722, Upadacitinib, Placebo for ABBV-722, Placebo for Upadacitinib	ClinicalTrials.gov
First posted	2026-11-12	ClinicalTrials.gov
Last updated	2026-11-12	ClinicalTrials.gov

Registered outcomes 11

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

List	Outcome	Time frame	Description	Source
Primary	Part 1 & Part 2: Achievement of Revised Composite Response Index in Systemic Sclerosis (rCRISS)-25	At Week 52	The rCRISS is a 2-step process wherein participants are determined to be considered as a responder or a non-responder. The first step of the rCRISS accounts for worsening or incident cases of any internal organ involvement. If the participant meets any of the Step 1 criteria, they are considered a non-responder in the trial afterwards. Step 2 includes 5 core set measures. The FVC% is evaluated to see if the change is at least 5%. The other 4 core set measures (modified Rodnan skin score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PGA) and clinician global assessment) are evaluated for change of at least 25%. A responder is a participant who has relative improvement on at least 2 of the 5 core set measures without worsening on more than 1 core set measure	ClinicalTrials.gov
Primary	Part 1 & Part 2: Number of Participants Experiencing Adverse Events	Up to 112 Weeks	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	ClinicalTrials.gov
Secondary	Part 1 & Part 2: Change from Baseline in Forced Vital Capacity (FVC) (mLs) in participants with interstitial lung disease (ILD) at Baseline	At Week 52	FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.	ClinicalTrials.gov
Secondary	Part 1 & Part 2: Absolute change from Baseline in percent-predicted FVC in subjects with ILD at Baseline	At Week 52	FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity.	ClinicalTrials.gov
Secondary	Part 1 & Part 2: Change from Baseline in modified Rodnan skin score (mRSS) in all participants with mRSS score of > 10 at Baseline	At Week 52	The mRSS is a clinical assessment tool used to evaluate skin thickness in patients with SSc, a condition characterized by skin thickening and fibrosis. Skin thickness will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites.	ClinicalTrials.gov
Secondary	Part 1 & Part 2: Improvement from Baseline in each of the following 3 components of the rCRISS-25 evaluated separately: FVC , mRSS and Health Assessment Questionnaire Disability Index (HAQ-DI)	At Week 52	* Percentage of participants with \>= 5% increase from the Baseline in predicted FVC * Percentage of participants with \>=25% decrease from the Baseline in mRSS * Percentage of participants with \>=25% decrease from the Baseline in HAQ-DI	ClinicalTrials.gov
Secondary	Part 1 & Part 2: Change from Baseline in joint pain as assessed by the SSc Daily Diary	At Week 52		ClinicalTrials.gov
Secondary	Part 1 & Part 2: Change from Baseline in the Scleroderma Skin Patient Reported Outcome (SSPRO) physical effects domain	At Week 52		ClinicalTrials.gov
Secondary	Part 1 & Part 2: Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)	At Week 52	The HAQ DI is a questionnaire that determines physical function.	ClinicalTrials.gov
Secondary	Part 1 & Part 2: Improvement from Baseline in each of the following 2 components of the rCRISS-25 evaluated separately: PGA and CGA	At Week 52	* Percentage of participants with \>= 25% decrease from the Baseline in Patient Global Assessment (PGA) * Percentage of participants with \>= 25% decrease from the Baseline in Clinician Global Assessment (CGA)	ClinicalTrials.gov
Secondary	Part 1 & Part 2: Absolute change from Baseline in percent-predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (corrected for hemoglobin [Hb]) in participants with interstitial lung disease (ILD) at Baseline	At Week 52		ClinicalTrials.gov

Outcomes 0

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

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

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

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

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

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

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	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 0

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

Comparison	Source

Tests 0

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

Test	Named as	Source

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)