Systemic SclerosisPhase 2ABATENCT06210945
Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
A Phase 2 study testing 10 mg/kg CM-101 in people with Systemic Sclerosis, run by ChemomAb Ltd. at 1 site in United States.
Trial summary
This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- 10 mg/kg CM-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of systemic sclerosis based on the 2013 ACR-EULAR Classification Criteria for SSc with a disease duration of ≤7 years as defined by the date of onset of the first non-Raynaud's symptom. Systemic sclerosis may be of limited or diffuse type.
- A serum level of CCL24 ≥400 pg/mL at Screening
- Presence of one of the below confirming active disease at Screening:
- Skin involvement with mRSS ≥15 b. Presence of interstitial lung disease at Screening, evidenced by >10% involvement at HRCT (historic HRCT performed within 12 weeks of Screening may be used if the images are available to be sent to the central reader) and at least one of the following at Screening: i. C-reactive protein (CRP) ≥6 mg/L, or ii. Erythrocyte sedimentation rate (ESR) ≥28 mm/hr, or iii. Platelet count ≥(330,000/microliter), or iv. Serum level of CCL24 ≥1,000 pg/mL c. Current digital ulcer and at least one of the following at Screening: i. CRP ≥6 mg/L, or ii. ESR ≥28 mm/hr, or iii. Platelet count ≥330,000/μL), or iv. Serum level of CCL24 ≥1,000 pg/mL
- If under active immunosuppressive treatment for SSc, treatment must be stable
- ≥12 weeks before Screening with intention to continue with no change in dose from Screening through the end of study. Hydroxychloroquine (or similar antimalarial such as chloroquine) use is allowed and may be combined with up to one of the following:
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- Methotrexate (maximum dose 25 mg/week),
- Azathioprine (maximum dose 200 mg/day),
- Mycophenolate mofetil (MMF)/mycophenolic acid (MPA) (maximum dose 2 g/dayMMF or equivalent).
- Oral corticosteroids of prednisone (or equivalent) ≤10 mg/day are allowed but not required and if present, must be stable for 30 days prior to Screening.
- If under treatment with the following, treatment must be stable for ≥8 weeks before Screening with the intention to continue with no change in dose from Screening through the end of study:
- Endothelin receptor antagonist, such as macitentan, bosentan, ambrisentan
- Phosphodiesterase type 5 inhibitors, such as sildenafil and tadalafil.
- Negative serum pregnancy test for biologically female patients of childbearing potential
- Men and women with reproductive potential are required to use a highly effective means of contraception through the course of the study
Who cannot join
- Systemic sclerosis-like illness associated with environmental or ingested agents such as toxic rapeseed oil, vinyl chloride, or bleomycin.
- Rheumatic autoimmune disease other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, undifferentiated connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren's syndrome, and eosinophilic myalgia syndrome when classification or diagnostic criteria for those diseases are met.
- Systemic sclerosis with end-stage organ involvement at Screening, including:
- Currently or anticipating placement on an organ transplantation list, or has received an organ transplant
- Renal crisis within 6 months before Screening
- Interstitial lung disease with FVC% < 45 or requiring constant oxygen therapy. Oxygen used to aid sleep or exercise is allowed.
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- Pulmonary hypertension requiring constant oxygen therapy or continuous intravenous treatment with prostaglandins. Oxygen used to aid sleep or exercise is allowed.
- Gastrointestinal dysmotility requiring total parenteral nutrition or hospitalization within 6 months before Screening.
- Use of following treatment(s) during the study or within the times noted:
- Within 26 weeks prior to Screening: cyclophosphamide, rituximab
- Within 12 weeks prior to Screening: tocilizumab, thalidomide, cyclosporine, pirfenidone, or tyrosine kinase inhibitors (e.g., nintedanib)
- Within 6 weeks prior to Screening: ultraviolet (UV) phototherapy
- Within 30 days prior to Screening: systemic corticosteroids at doses greater than 10mg/day prednisone or equivalent
- Other monoclonal antibodies not listed, please consult with the Medical Monitor regarding appropriate discontinuation period
- Anticipated to require the following treatments during the study: cell depleting therapy, chlorambucil, total lymphoid radiation, anti-thymocyte globulin, plasmapheresis, extra-corporeal photopheresis or bone marrow transplant. If prior use, consult Medical Monitor.
- Participation in another research study of an investigational drug or device within 10 weeks of Screening or received treatment with any investigational agent within 30 days or 5 elimination half-lives (whichever is longer) of the investigational drug prior to Screening.
- Prior exposure to CM-101
- Any major surgery (including joint surgery) within 8 weeks prior to Screening or have surgery scheduled during the study duration.
- Receipt of a live/attenuated vaccine within 10 days of study Screening.
- Cancer, history of cancer or lymphoproliferative disorder within the previous 5 years (other than adequately treated nonmetastatic basal cell skin cancer or squamous cell skin cancer that has not recurred for at least 1 year prior to Screening; history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to Screening).
- Concurrent serious medical condition which, in the opinion of the Investigator, makes the patient inappropriate for this study such as but not limited to poorly controlled chronic heart failure, clinically meaningful arrhythmia, severe pulmonary or systemic hypertension, hepatic impairment, poorly controlled diabetes, unstable atherosclerotic cardiovascular disease, or severe peripheral vascular disease.
- Any clinically significant disease or laboratory abnormality at Screening which may interfere with the study evaluation and/or safety of the patient including the following:
- hemoglobin <9 g/dL
- absolute neutrophils <1.0 × 10-9/L
- white blood cells (WBC) <3,000/mm3
- platelets <100,000/mm3
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN)
- total bilirubin >1.5× ULN.
- History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), or a previously positive result for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), or anti-HIV 1 or 2. Local testing may be performed based on Investigator judgment if there are no historical values or there is an indication for testing.
- Known active bacterial, viral, fungal, mycobacterial, or other systemic infection including any infected ulcer(s); or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks of Screening; or any infection requiring antibiotic therapy within 2 weeks of Screening.
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
- Currently pregnant or breastfeeding at entry into this study.
- History of severe depression, psychosis, or suicidal ideation, or a history of alcohol abuse or drug addiction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Proof of Biology Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.
Read the detailed description
This study will consist of a screening period, double-blind treatment period, open-label treatment period, and safety follow-up. Approximately 45 patients will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo. The study drug or placebo, will be administered as a 60-minute intravenous (IV) infusion once every 3 weeks for a treatment coverage of 24 weeks.
- Conditions
- Systemic Sclerosis
- Being tested
- 10 mg/kg CM-101, Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg/kg CM-101Drug
10 mg/kg CM-101
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CM-101 | Experimental | CM-101 will be administered Receives: Drug: 10 mg/kg CM-101 |
| Placebo | Placebo comparator | Placebo will be administered Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs)
Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs)
Measured: 24-weeks
Secondary outcomes (12)
To evaluate change from Baseline in serum biological markers - growth factors and cytokines
To evaluate change from Baseline in serum biological markers, including but not limited to growth factors and cytokines (IL6, CCL2, CXCL9, CXCL10, CXCL11, and C-X3-C motif ligand [CX3CL]1).
Measured: 24 weeks
To evaluate change from Baseline in serum biological markers - adhesion molecules
To evaluate change from Baseline in serum biological markers - adhesion molecules (intercellular adhesion molecule 1 [ICAM-1], P-selectin, vascular cell adhesion protein 1 [VCAM-1], and E-selectin).
Measured: 24 weeks
To evaluate change from Baseline in serum biological markers - vascular
To evaluate change from Baseline in serum biological markers - vascular (vascular endothelial growth factor [VEGF], Endothelin-1, and brain natriuretic peptide [BNP])
Measured: 24 weeks
To evaluate change from Baseline in serum biological markers - lung injury
To evaluate change from Baseline in serum biological markers - lung injury (Krebs von den Lungen 6 [KL-6]
Measured: 24 weeks
To evaluate change from Baseline in serum biological markers - surfactant protein D
To evaluate change from Baseline in serum biological markers - surfactant protein D [SP-D], and CCL18)
Measured: 24 weeks
To evaluate change from Baseline in serum biological markers - extracellular matrix related markers
To evaluate change from Baseline in serum biological markers - extracellular matrix related markers (collagens, matrix metalloproteinases [MMP]s, tissue inhibitors of metalloproteinases [TIMPs], and ELF).
Measured: 24 weeks
Observed maximum plasma concentration - Cmax
To characterize the PK properties of CM-101 following repeated administrations of CM-101
Measured: 24 weeks
Time to reach the observed maximum plasma concentration - Tmax
To characterize the PK properties of CM-101 following repeated administrations of CM-101
Measured: 24 weeks
Area under the plasma concentration-time curve extrapolated to infinity, calculated as: AUC∞ = AUClast + Clast/λz, where AUClast is the last measurable concentration - AUC∞
To characterize the PK properties of CM-101 following repeated administrations of CM-101
Measured: 24 weeks
Elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve - λz
To characterize the PK properties of CM-101 following repeated administrations of CM-101
Measured: 24 weeks
To evaluate target engagement in serum
To evaluate target engagement in serum following multiple repeated administrations of CM-101 dosing by analyzing CCL24 and CM-101 levels
Measured: 24 weeks
anti-drug antibodies
To evaluate the development of anti-drug antibodies following repeated administrations of CM-101
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: pending financial resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChemomAb Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Frankel, MD, Study director, ChemomAb Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210945
- Sponsor's protocol ID
- CM-101-SSC-203
- Acronym
- ABATE
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Proof of Biology Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06210945
- Acronym / sponsor ID
- ABATE / CM-101-SSC-203
- Conditions
- Systemic Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: pending financial resources
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- ChemomAb Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.
Detailed description
This study will consist of a screening period, double-blind treatment period, open-label treatment period, and safety follow-up. Approximately 45 patients will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo. The study drug or placebo, will be administered as a 60-minute intravenous (IV) infusion once every 3 weeks for a treatment coverage of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM-101 | Experimental | Drug: 10 mg/kg CM-101CM-101 will be administered |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A diagnosis of systemic sclerosis based on the 2013 ACR-EULAR Classification Criteria for SSc with a disease duration of ≤7 years as defined by the date of onset of the first non-Raynaud's symptom. Systemic sclerosis may be of limited or diffuse type.
- A serum level of CCL24 ≥400 pg/mL at Screening
- Presence of one of the below confirming active disease at Screening:
- If under active immunosuppressive treatment for SSc, treatment must be stable
- ≥12 weeks before Screening with intention to continue with no change in dose from Screening through the end of study. Hydroxychloroquine (or similar antimalarial such as chloroquine) use is allowed and may be combined with up to one of the following:
Key exclusion criteria (33 listed)
- Systemic sclerosis-like illness associated with environmental or ingested agents such as toxic rapeseed oil, vinyl chloride, or bleomycin.
- Rheumatic autoimmune disease other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, undifferentiated connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren's syndrome, and eosinophilic myalgia syndrome when classification or diagnostic criteria for those diseases are met.
- Systemic sclerosis with end-stage organ involvement at Screening, including:
- Use of following treatment(s) during the study or within the times noted:
- Anticipated to require the following treatments during the study: cell depleting therapy, chlorambucil, total lymphoid radiation, anti-thymocyte globulin, plasmapheresis, extra-corporeal photopheresis or bone marrow transplant. If prior use, consult Medical Monitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mg/kg CM-10110 mg/kg CM-101 | Drug | CM-101 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs)
Time frame: 24-weeks
Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs)
12 secondary outcomes
To evaluate change from Baseline in serum biological markers - growth factors and cytokines
Time frame: 24 weeks
To evaluate change from Baseline in serum biological markers - adhesion molecules
Time frame: 24 weeks
To evaluate change from Baseline in serum biological markers - vascular
Time frame: 24 weeks
To evaluate change from Baseline in serum biological markers - lung injury
Time frame: 24 weeks
To evaluate change from Baseline in serum biological markers - surfactant protein D
Time frame: 24 weeks
To evaluate change from Baseline in serum biological markers - extracellular matrix related markers
Time frame: 24 weeks
Observed maximum plasma concentration - Cmax
Time frame: 24 weeks
Time to reach the observed maximum plasma concentration - Tmax
Time frame: 24 weeks
Area under the plasma concentration-time curve extrapolated to infinity, calculated as: AUC∞ = AUClast + Clast/λz, where AUClast is the last measurable concentration - AUC∞
Time frame: 24 weeks
Elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve - λz
Time frame: 24 weeks
To evaluate target engagement in serum
Time frame: 24 weeks
anti-drug antibodies
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Frankel, MD study director
ChemomAb Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 10 mg/kg CM-101 in people with Systemic Sclerosis, run by ChemomAb Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability will be assessed by treatment-emergent adverse events (TEAEs) (time frame: 24-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.