A Phase 2/3 interventional study of ABBV-722 and Upadacitinib in Systemic Sclerosis, sponsored by AbbVie. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by AbbVie · Phase 2/3, Interventional, and Treatment
Systemic sclerosis (SSc), also called scleroderma, is a rare long-term autoimmune disease that causes the body to make too much collagen (scar tissue), leading to hard, thick skin and sometimes damage to organs such as the lungs, heart, kidneys, or digestive system. An autoimmune disease is a condition where the body's immune system, which normally protects against germs, mistakenly attacks its own healthy tissues and organs.
The study has 2 parts. The main goal of Part 1 is to evaluate the safety and efficacy (how well the study treatment works) of ABBV-2294 (combination of ABBV-722 and upadacitinib) in adult participants with SSc that are currently receiving local standard of care treatment, and to determine the best dose of ABBV-2294 to be evaluated further. The main goal of Part 2 is to evaluate the safety and efficacy of the dose of ABBV-2294 determined in Part 1 when compared to placebo (looks like the study treatment but has no medicine in it) in adult patients with SSc that are currently receiving local standard of care treatment. Participants will undergo trial-related procedures throughout the study which may include physical exams, questionnaires, scans and imaging, and blood and urine tests.
ABBV-2294 (combination of ABBV-722 and upadacitinib) is an investigational drug being developed for the treatment of SSc in adult participants. At the start of Part 1, participants will be randomly assigned to receive Dose 1 of ABBV-722 and upadacitinib given together, Dose 2 of ABBV-722 and upadacitinib given together, ABBV-722 given alone, upadacitinib given alone, or placebo for 52 weeks. Participants that complete 52 weeks of treatment will be invited to join a 56-week extension period.
Participants that join Part 2 will be randomly assigned to receive either ABBV-2294 (dose determined in Part 1) or placebo for 52 weeks. Participants that complete 52 weeks of treatment will be invited to join a 104-week extension period. All participants that join the extension will receive ABBV-2294.
Participants 18 years of age and older diagnosed with Systemic sclerosis (SSc). Around 580 participants will be enrolled at approximately 200 sites worldwide.
Participants will receive upadacitinib and/or ABBV-722 oral tablets (or matching placebo) for 52 weeks in Part 1 with an optional 56-week extension period. Part 2 participants will receive ABBV-2294 (dose determined in Part 1) or matching placebo for 52 weeks with an optional 104-week extension period of open label ABBV-2294 (dose determined in Part 1).
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic, including screening, baseline, and scheduled visits. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
612 studies on the registry are indexed under Scleroderma, Systemic; 220 are open to participants now.
This study's planned enrollment of 580 is above the median of 37 across 448 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →AbbVie is the lead sponsor of 976 studies on the registry; 135 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are randomized to receive Dose 1: ABBV-2294 (combination of ABBV-722 and upadacitinib)
Drug: ABBV-722 · Drug: Upadacitinib
Participants are randomized to receive Dose 2: ABBV-2294 (combination of ABBV-722 and upadacitinib)
Drug: ABBV-722 · Drug: Upadacitinib
Participants are randomized to receive ABBV-722
Drug: ABBV-722
Participants are randomized to receive upadacitinib
Drug: Upadacitinib
Participants are randomized to receive placebo
Drug: Placebo for ABBV-722 · Drug: Placebo for Upadacitinib
Oral Tablet
Oral Tablet
Oral Tablet
Oral Tablet
Part 1 & Part 2: Achievement of Revised Composite Response Index in Systemic Sclerosis (rCRISS)-25
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
Time frame: At Week 52
Part 1 & Part 2: Number of Participants Experiencing Adverse Events
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.
Time frame: Up to 112 Weeks
Part 1 & Part 2: Change from Baseline in Forced Vital Capacity (FVC) (mLs) in participants with interstitial lung disease (ILD) at Baseline
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.
Time frame: At Week 52
Part 1 & Part 2: Absolute change from Baseline in percent-predicted FVC in subjects with ILD at Baseline
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.
Time frame: At Week 52
Part 1 & Part 2: Change from Baseline in modified Rodnan skin score (mRSS) in all participants with mRSS score of > 10 at Baseline
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.
Time frame: At Week 52
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)
* 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
Time frame: At Week 52
Part 1 & Part 2: Change from Baseline in joint pain as assessed by the SSc Daily Diary
Time frame: At Week 52
Part 1 & Part 2: Change from Baseline in the Scleroderma Skin Patient Reported Outcome (SSPRO) physical effects domain
Time frame: At Week 52
Part 1 & Part 2: Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ DI is a questionnaire that determines physical function.
Time frame: At Week 52
Part 1 & Part 2: Improvement from Baseline in each of the following 2 components of the rCRISS-25 evaluated separately: PGA and CGA
* 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)
Time frame: At Week 52
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
Time frame: At Week 52
No study locations are listed for this record.
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Statistical analysis plan
Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2035, 102 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: ABBV-722 · Upadacitinib