Raynaud PhenomenonPhase 2NCT04388176
Cold Challenge With C21 in RP
A Phase 2 study testing C21 in people with Raynaud Phenomenon and Systemic Sclerosis, run by Vicore Pharma AB at 1 site in United Kingdom.
Trial summary
This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's phenomenon secondary to systemic sclerosis. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Raynaud Phenomenon, Systemic Sclerosis
- What is being tested?
- C21
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jan 2020to 14 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any trial related procedures are performed.
- Subjects diagnosed with SSc according to European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
- Age 19-75 years inclusive
- RP secondary to SSc as determined by the investigator, and with a typical frequency of attacks during the winter months (November-March) of on average at least 5 per week.
Who cannot join
- Smoking (including E-cigarettes) or use of nicotine replacement therapy for three months prior to Visit 1 and during the trial.
- BMI >30
- Mixed connective tissue disease or "overlap" (i.e. those who satisfy more than one set of ACR criteria for a rheumatic disease).
- Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions which in the opinion of the investigator makes the patient inappropriate for this study
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
- Planned major surgery within the duration of the study
Show all 31Show fewer
- Subjects who forsake any alcohol intake or have known uncontrolled allergic conditions or allergy/hypersensitivity to any components of the trial drug or placebo excipients (see Section 7.1)
- Blood donation (or corresponding blood loss) within three months prior to Visit 1
- Treatment with any of the medications listed below within 4 weeks prior to Visit 1:
- Any dose-change or initiation of vasoactive substances
- , and not able or willing to withhold these medications for 3 days preceding Visit 2 and Visit 3, respectively
- Iloprost
- Any treatment with CYP3A4 inducers (e.g. rifampicin, phenytoin, St John's Wort)
- Any treatment with CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, nefazodone, itraconazole, ritonavir)
- Any treatment with medicines that are substrates of CYP1A2, CYP3A4 or CYP2C9 with a narrow therapeutic range
- Any experimental drug
- Any systemic immunosuppressive therapy other than:
- Inhaled corticosteroids which can be used throughout the trial period
- The continuation of stable doses of <10 mg prednisolone
- Mycophenolate mofetil (MMF) which must be withheld for 3 days preceding Visit 2 and Visit 3
- Any of the following findings at the time of screening:
- Finger temperature below 27°C after acclimatising at an ambient temperature of 23°C for a period of 20 minutes
- Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator
- Positive results for HBsAg, HCVAb or HIV 1+2 Ag/Ab
- Positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
- Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator
- Pregnant or breast-feeding female subjects.
- Female subjects of childbearing potential not willing to use contraceptive methods described in Section 5.3.1.
- Male subjects not willing to use contraceptive methods described in Section 5.3.1.
- Participation in any other interventional trial during the trial period
- Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Rheumatology, Salford Royal Hospital
Manchester, Salford, M6 8HD
About this study
Official title: A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)
This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's phenomenon secondary to systemic sclerosis. The purpose of the trial is to achieve a vasodilatory effect in subjects with Raynaud's phenomenon by stimulation of the AT2R (angiotensin II type 2 receptor) with C21.
- Conditions
- Raynaud Phenomenon, Systemic Sclerosis
- Being tested
- C21, Placebo
- Keywords
- Systemic sclerosis, Raynaud's phenomenon, Vasoconstriction
- Medical subject headings
- Raynaud Disease, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C21Drug
C21 as first treatment
C21Drug
C21 as second treatment
PlaceboDrug
Placebo as second treatment
PlaceboDrug
Placebo as first treatment
| Study group | Role | What they receive |
|---|---|---|
| C21 followed by placebo | Experimental | Not described Receives: Drug: C21; Drug: Placebo |
| Placebo followed by C21 | Experimental | Not described Receives: Drug: C21; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for Rewarming of Each Finger After Cold Challenge (AUC) as Measured by Thermography
Area under the curve for rewarming of each finger after cold challenge as measured by thermography for 15 min
Measured: For 15 min after cold challenge (40-55 min after IMP [investigational manufacturing product] administration)
Secondary outcomes (3)
Maximum Skin Temperature After Rewarming (MAX)
Maximum skin temperature after rewarming within 15 min after cold challenge
Measured: For 15 min after cold challenge (40-55 min after IMP administration)
The Distal Dorsal Difference, Defined as the Difference in Temperature Between the Dorsum and the Finger (DDD)
The distal dorsal difference, defined as the difference in temperature between the dorsum and the finger (DDD), from administration of IMP until before cold challenge (0 to 40 min)
Measured: Baseline, 10, 20, 30 and 40 min
Gradient of Rewarming in the First 2 Minutes Post-cold Challenge (GRAD)
Measured: 2 min after cold challenge (40-42 min after IMP administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start3 Jan 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud PhenomenonStudies 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
- Crossover
- Model description
- This is a randomised, double-blind, placebo-controlled cold challenge study. A cross-over design is applied to control for inter-individual variability in response to cold challenge.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Responsible party
- Sponsor
- Investigators
- Ariane Herrick, MD, Principal investigator, Department of Rheumatology Salford Royal Hospital, Manchester,United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388176
- Sponsor's protocol ID
- VP-C21-004
- Other IDs
- 2019-003203-35, 2019
- Status last verified
- Jul 2022
- First submitted
- 11 May 2020
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Herrick AL, Batta R, Overbeck K, Raud J, Manning J, Murray A, Dinsdale G, Tornling G. A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud's. Rheumatology (Oxford). 2023 Feb 1;62(2):824-828. doi: 10.1093/rheumatology/keac426.
PubMed 35894657
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-center, Randomised, Double-blind, Placebo-controlled, Cross-over Cold Challenge Study Investigating the Effect of C21 on Cold-induced Vasoconstriction in Subjects With Raynaud's Phenomenon (RP) Secondary to Systemic Sclerosis (SSc)
- ClinicalTrials.gov ID
- NCT04388176
- Acronym / sponsor ID
- VP-C21-004
- Conditions
- Raynaud Phenomenon, Systemic Sclerosis
- Keywords
- Systemic sclerosis, Raynaud's phenomenon, Vasoconstriction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's phenomenon secondary to systemic sclerosis. The purpose of the trial is to achieve a vasodilatory effect in subjects with Raynaud's phenomenon by stimulation of the AT2R (angiotensin II type 2 receptor) with C21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomised, double-blind, placebo-controlled cold challenge study. A cross-over design is applied to control for inter-individual variability in response to cold challenge.
| Arm | Type | Receives |
|---|---|---|
| C21 followed by placebo | Experimental | Drug: C21, Drug: Placebo |
| Placebo followed by C21 | Experimental | Drug: C21, Drug: Placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent must be obtained before any trial related procedures are performed.
- Subjects diagnosed with SSc according to European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
- Age 19-75 years inclusive
- RP secondary to SSc as determined by the investigator, and with a typical frequency of attacks during the winter months (November-March) of on average at least 5 per week.
Key exclusion criteria (31 listed)
- Smoking (including E-cigarettes) or use of nicotine replacement therapy for three months prior to Visit 1 and during the trial.
- BMI >30
- Mixed connective tissue disease or "overlap" (i.e. those who satisfy more than one set of ACR criteria for a rheumatic disease).
- Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions which in the opinion of the investigator makes the patient inappropriate for this study
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I
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 |
|---|---|---|
| C21C21 as first treatment | Drug | C21 followed by placebo |
| C21C21 as second treatment | Drug | Placebo followed by C21 |
| PlaceboPlacebo as second treatment | Drug | C21 followed by placebo |
| PlaceboPlacebo as first treatment | Drug | Placebo followed by C21 |
Primary outcome
Area Under the Curve for Rewarming of Each Finger After Cold Challenge (AUC) as Measured by Thermography
Time frame: For 15 min after cold challenge (40-55 min after IMP [investigational manufacturing product] administration)
Area under the curve for rewarming of each finger after cold challenge as measured by thermography for 15 min
3 secondary outcomes
Maximum Skin Temperature After Rewarming (MAX)
Time frame: For 15 min after cold challenge (40-55 min after IMP administration)
The Distal Dorsal Difference, Defined as the Difference in Temperature Between the Dorsum and the Finger (DDD)
Time frame: Baseline, 10, 20, 30 and 40 min
Gradient of Rewarming in the First 2 Minutes Post-cold Challenge (GRAD)
Time frame: 2 min after cold challenge (40-42 min after IMP administration)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35894657Herrick AL, Batta R, Overbeck K, Raud J, Manning J, Murray A, Dinsdale G, Tornling G. A phase 2 trial investigating the effects of the angiotensin II type 2 receptor agonist C21 in systemic sclerosis-related Raynaud's. Rheumatology (Oxford). 2023 Feb 1;62(2):824-828. doi: 10.1093/rheumatology/keac426.
Related trials for Raynaud Phenomenon
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruitingPhase 3
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Not yet recruitingPhase 2
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Not yet recruitingPhase 3
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
Buerger Disease, Raynaud Syndrome
RecruitingPhase 2/3
Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk
Scleroderma, Systemic Sclerosis
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.
Ariane Herrick, MD principal investigator
Department of Rheumatology Salford Royal Hospital, Manchester,United Kingdom
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 C21 in people with Raynaud Phenomenon and Systemic Sclerosis, run by Vicore Pharma AB at 1 site in United Kingdom.
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 4 inclusion and 31 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: finished, as of the sponsor's last update on 18 May 2023. 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 Kingdom. 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. 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?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve for Rewarming of Each Finger After Cold Challenge (AUC) as Measured by Thermography (time frame: For 15 min after cold challenge (40-55 min after IMP [investigational manufacturing product] administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04388176, which also lists 1 linked publication.
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 18 May 2023.