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RosaceaPhase 2STOP RosNCT04419259

Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea

A Phase 2 study testing AMG 334 in people with Rosacea, run by Messoud Ashina at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An exploratory open-label study of rosacea patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent redness and flushing attributed to rosacea. Approximately 30 subjects will be included in the study and receive erenumab 140 mg for three months. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rosacea
What is being tested?
AMG 334
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteDenmark
Study dates
9 Jun 2020to Aug 2021
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women between ages 18 - 65 years who have suffered from rosacea for at least 12 months.
  • If patient has concurrent migraine, a daily headache diary must be filled out
  • Criteria to be met prior to enrollment in the 4-week run-in period:
  • •Erythematotelangiectatic rosacea with a minimum of 15 days of either:
  • PSA > 2, and/or
  • Moderate, severe or extreme flushing measured by the Flushing Assessment Tool (FAST)

Who cannot join

  • Systemic treatment for rosacea ended less than five half-lives or 28 days ago, whichever is longest
  • Topical treatment for rosacea ended less than five half-lives or 28 days ago, whichever is longest
  • Cardiovascular disease of any kind, including cerebrovascular disease
  • Hypertension on the experimental day (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Hypotension on the experimental day (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
  • Ongoing psychiatric disease of any kind - unless it has been effectively treated with a stable treatment for at least 2 months.
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  • Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient
  • Pregnant or breastfeeding women, or women expecting to conceive during the study
  • Women of childbearing potential who are unwilling to use an acceptable method of effective contraception during treatment through 16 weeks after the last dose of erenumab. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots/injections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation), or two barrier methods (each partner must use one barrier method) with spermicide - males must use a condom with spermicide; females must choose either a diaphragm with spermicide, OR cervical cap with spermicide, OR contraceptive sponge with spermicide. Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:
  • Age ≥ 55 years with cessation of menses for 12 or more months, OR
  • Age < 55 years but no spontaneous menses for at least 2 years, OR
  • Age < 55 years and spontaneous menses within the past 1 year, but currently amenorrhoeic (e.g. spontaneous or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved OR Underwent bilateral oophorectomy OR Underwent hysterectomy OR Underwent bilateral salpingectomy
  • Known sensitivity to any component of erenumab
  • Previously randomized into an erenumab study
  • Member of investigational site staff or relative of the investigator
  • Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge

Trial locations and contacts

1 site in 1 country.

Nita KF Wienholtz, MD contact

0045-38634612

nita.wienholtz@regionh.dk

Denmark1 site, 1 recruiting

  • Danish Headache Center

    Glostrup Municipality, Dk-2600

    Nita Wienholtz, MD

    Messoud Ashina, MD, PhD, DMSc

    Recruiting

Other trials in Denmark

About this study

Official title: An Open Label Study to Evaluate the Efficacy and Tolerability of Erenumab in the Management of Persistent Redness and Flushing in Rosacea

An exploratory open-label study of rosacea patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent redness and flushing attributed to rosacea. Approximately 30 subjects will be included in the study and receive erenumab 140 mg for three months. The study will begin June 2020 and is expected to last nine months.

Conditions
Rosacea
Being tested
AMG 334
Medical subject headings
Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 334Drug

    Also called Erenumab

    30 subjects with rosacea will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)

Study groups in NCT04419259
Study groupRoleWhat they receive
ErenumabExperimental30 subjects with rosacea will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)
Receives: Drug: AMG 334

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of erenumab on days of flushing

    Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 12. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)

    Measured: 12 weeks

Secondary outcomes (13)

  1. Effect of erenumab on erythema

    Mean change in erythema from Baseline to week 4, 8 and 12. Will be evaluated by Clinicians Erythema Assessment (CEA)

    Measured: 12 weeks

  2. Effect of erenumab on quality of life: Dermatology Life Quality Index (DLQI)

    Mean change in quality of life from Baseline to week 4, 8 and 12. Will be evaluated by Dermatology Life Quality Index (DLQI)

    Measured: 12 weeks

  3. Proportion of patients that reach a 50% reduction in number of days with flushing

    To evaluate the proportion of patients with at least 50% reduction in number of days with moderate, severe or extreme flushing. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)

    Measured: 12 weeks

  4. Effect of erenumab on days of flushing

    Mean change in number of days with moderate, severe or extreme flushing from Baseline to week 4 and 8. Evaluated by the Flushing Assessment (FAST) Tool part II (moderate, severe or very severe flushing is defined as a score of 4-10 on FAST)

    Measured: 8 weeks

  5. Effect of erenumab on depression

    Mean change in depressive symptoms from Baseline to week 4, 8 and 12. Evaluated by Hospital Anxiety and Depression Scale (HADS).

    Measured: 12 weeks

  6. Effect of erenumab on overall rosacea symptoms

    Proportion of patients with Investigator's Global Assessment (IGA) '0' or '1' with an at least 2-point reduction from baseline to week 4, 8 and 12.

    Measured: 12 weeks

  7. Effect of erenumab on inflammatory lesions

    Mean change in Inflammatory Lesion Count (ILC) from baseline to week 4, 8 and 12

    Measured: 12 weeks

  8. Proportion of patients that reach a 50% reduction in self-assessed rosacea symptoms

    Proportion of patients with at least 50% reduction in number of days with Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.

    Measured: 12 weeks

  9. Effect of erenumab on self-assessed rosacea symptoms

    Mean change in Patient's Self-Assessment (PSA) above 2 from Baseline to week 4, 8 and 12.

    Measured: 12 weeks

  10. Effect of erenumab on depressive symptoms

    Mean change in Quicky Inventory Depressive Symptomatology (QIDS) from Baseline to week 4, 8 and 12

    Measured: 12 weeks

  11. Effect of erenumab on overall rosacea severity

    Mean change in overall rosacea severity from Baseline to week 4, 8 and 12. Evaluated by Rosacea Area and Severity Index (RASI)

    Measured: 12 weeks

  12. Effect of erenumab on rosacea symptoms

    Mean change in rosacea symptoms from Baseline to week 4, 8 and 12. Evaluated by Rosacea Clinical Scorecard (RCS)

    Measured: 12 weeks

  13. Effect of erenumab on rosacea-specific quality of life: Rosacea-specific Quality-of-Life index (RosaQoL)

    Mean change in rosacea-specific quality of life from Baseline to week 4, 8 and 12. Evaluated by the Rosacea-specific Quality-of-Life index (RosaQoL)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2020
  2. Study start9 Jun 2020
  3. Primary completionMar 2021 (estimated)
  4. Study completionAug 2021 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419259
Sponsor's protocol ID
ROS031019
Acronym
STOP Ros
Status last verified
Jun 2020
First submitted
3 Jun 2020
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wienholtz NKF, Christensen CE, Do TP, Frifelt LEW, Snellman J, Lopez-Lopez CL, Egeberg A, Thyssen JP, Ashina M. Erenumab for Treatment of Persistent Erythema and Flushing in Rosacea: A Nonrandomized Controlled Trial. JAMA Dermatol. 2024 Jun 1;160(6):612-619. doi: 10.1001/jamadermatol.2024.0408.

    PubMed 38630457

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 334 in people with Rosacea, run by Messoud Ashina at 1 site in Denmark.

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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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 Denmark. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nita KF Wienholtz, MD (0045-38634612, nita.wienholtz@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of erenumab on days of flushing (time frame: 12 weeks). 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 NCT04419259, 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 11 Jun 2020.

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