DermatomyositisPhase 2NCT05361109
Baricitinib for Cutaneous Dermatomyositis
A Phase 2 study testing Baricitinib in people with Dermatomyositis, run by University of Washington at 1 site in United States.
Trial summary
This is a phase 2, single-center study in patients with active cutaneous DM who have had an inadequate response. An inadequate response is defined as no improvement with standard of care treatment based on the investigator's opinion. All subjects will initially receive baricitinib 2mg daily for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-nursing female
- Age ≥18 years at time of consent
- Typical cutaneous DM manifestations including heliotrope rash, Gottron's papules/sign, V-sign, shawl sign, holster sign, confirmed by skin biopsy, with or without DM muscle disease classified based on the Bohan and Peter criteria at screening and baseline visit
- Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score ≥ 12 corresponding to moderate to severe disease activity at screening and baseline visit
- Active disease (i.e., CDASI ≥ 12) despite adequate prior treatment experience with corticosteroids, immunosuppressants, or biologics
- Patients taking methotrexate must be on a stable dose for at least 4 weeks prior to baricitinib initiation
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- Patients who have received mycophenolate, azathioprine, cyclosporine, or tacrolimus must have discontinued for at least 4 weeks prior to signing the informed consent.
- Patients who have received IVIG, rituximab or any other biologic agents must have discontinued for at least 6 months prior to signing the informed consent
- Patients taking oral corticosteroids, the dose must be ≤ 15 mg/day prednisone or equivalent and not be changed for 2 weeks prior to baseline visit
- Females of childbearing potential and males with female partners of childbearing potential may participate in this study only if using a highly effective method of contraception
- Highly Effective Methods of Contraception:
- A tubal ligation, or surgical sterilization
- FDA approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings, or hormonally impregnated intrauterine device (IUD)
- Intrauterine device (IUD)
- Abstinence if this method of contraception coincides with normal lifestyle choice of the participant. Abstinence for the duration of the study is not an acceptable method of contraception for the purposes of this study.
Who cannot join
- Previous treatment with baricitinib.
- Previous treatment with tofacitinib or updacitinib.
- Current use of strong Organic Anion Transporters 3 (OAT3) inhibitors including probenecid.
- Uncontrolled or rapidly progressive myositis or interstitial lung disease at the discretion of the investigator which is likely to warrant escalation in therapy beyond permitted background medications.
- Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer).
- Patients who are known to be positive for the anti-TIF1-γ (p155/140) or anti-NXP2 autoantibody unless they are determined not to be associated with malignancy at the discretion of the investigator.
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- Other inflammatory diseases that might confound the evaluations of efficacy including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), psoriatic arthritis, inflammatory bowel disease.
- Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including HIV, Hepatitis B or C, latent TB (TB not adequately treated according to guidelines)
- History of recurrent herpes zoster, disseminated (multi-dermatomal) herpes zoster, disseminated herpes simplex or ophthalmic zoster. Herpes zoster lesions within 90 days prior to screening.
- Primary or secondary immunodeficiency.
- Current uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease, which, in the opinion of the investigator, might place the patient at unacceptable risk for participation in this study.
- History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix and non-melanoma skin carcinoma.
- History of lymphoproliferative disease, including lymphoma, and monoclonal gammopathy of undetermined significance.
- History of venous thromboembolism, including deep vein thrombosis and pulmonary embolism.
- History of alcohol, drug, or chemical abuse within one year prior to signing the informed consent form.
- Laboratory exclusion criteria within 60 days of Consent including
- Hemoglobin (Hgb) < 8g/dL
- White Blood Count (WBC) < 3,000/μL fidential Page 13 of 40
- Absolute Neutrophil Count (ANC) < 1,500/μL
- Absolute Lymphocyte Count (ALC) < 800/μL
- Platelets < 100,000/μL
- eGFR < 60 ml/min
- ALT or AST >1.5 times ULN not due to DM.
- Major surgery within 8 weeks prior to Screening or planned major surgery at any time during participation in the study.
- Immunization with a live/attenuated vaccine within 4 weeks prior to Screening.
- Pregnant or nursing women, or women of child-bearing potential who plan to become pregnant prior to 14 weeks after the last dose of baricitinib treatment.
- Patients of reproductive potential not willing to use a highly effective method of contraception as defined in Section 5.3.1.10.
- Prisoners, or subjects who are compulsory detained, or cannot provide informed consent without the use of a legally authorized representative (LAR).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Baricitinib in Subjects With Cutaneous Dermatomyositis
This is a phase 2, single-center study in patients with active cutaneous DM who have had an inadequate response. An inadequate response is defined as no improvement with standard of care treatment based on the investigator's opinion.
All subjects will initially receive baricitinib 2mg daily for 8 weeks. If no unexpected serious adverse events related to baricitinib have occurred during the first 8 weeks of treatment in the opinion of the investigator, the dose will be increased to 4 mg daily for 16 weeks. Visits are scheduled at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks. Evaluation of primary endpoint occurs at week 24. All subjects receive a phone call from study
- Conditions
- Dermatomyositis
- Being tested
- Baricitinib
- Keywords
- cutaneous, dermatomyositis, baricitinib
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called Olumiant
The investigational medicinal product (IP) for this study is baricitinib 2mg. The dose will be administered as one 2mg tablet by mouth once daily for the first 8 weeks of study. If no unexpected serious adverse events related to baricitinib in the opinion of the investigator occur during the first 8 weeks of treatment, the dose will be increased to two 2mg tablets (4mg daily) for the remaining 16 weeks of study. All study participants will take baricitinib in combination with standard of care background therapy.
| Study group | Role | What they receive |
|---|---|---|
| Barcitinib | Experimental | All subjects will initially receive baricitinib 2mg daily for 8 weeks. If no unexpected serious adverse events related to baricitinib have occurred during the first 8 weeks of treatment in the opinion of the investigator, the dose will be increased to 4 mg daily for 16 weeks. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Disease Activity Severity Index (CDASI) activity score
Change in Cutaneous Disease Activity Severity Index (CDASI) activity score (0-100), higher scores mean a worse outcome
Measured: 24 Weeks
Secondary outcomes (5)
Cutaneous Disease Activity Severity Index (CDASI) activity score
Change in Cutaneous Disease Activity Severity Index (CDASI) activity score (0-100), higher scores mean a worse outcome
Measured: 12 weeks
International Myositis Assessment & Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Change in International Myositis Assessment \& Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Measured: 12 weeks and 24 weeks
SF-36
Change in SF-36
Measured: 12 weeks and 24 weeks
Dermatology Life Quality Index (DLQI)
Change in Dermatology Life Quality Index (DLQI)
Measured: 12 weeks and 24 weeks
Adverse event
Adverse event monitoring
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 posted4 May 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: Difficulty recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwanghoon (Bobby) Han, University of Washington
- Investigators
- Kwanghoon Han, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361109
- Sponsor's protocol ID
- STUDY00014444
- Other IDs
- CUDM001
- Status last verified
- Aug 2023
- First submitted
- 3 Apr 2022
- Last updated
- 1 Sep 2023
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Baricitinib in Subjects With Cutaneous Dermatomyositis
- ClinicalTrials.gov ID
- NCT05361109
- Acronym / sponsor ID
- STUDY00014444
- Conditions
- Dermatomyositis
- Keywords
- cutaneous, dermatomyositis, baricitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 4 May 2022 (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 is a phase 2, single-center study in patients with active cutaneous DM who have had an inadequate response. An inadequate response is defined as no improvement with standard of care treatment based on the investigator's opinion.
All subjects will initially receive baricitinib 2mg daily for 8 weeks. If no unexpected serious adverse events related to baricitinib have occurred during the first 8 weeks of treatment in the opinion of the investigator, the dose will be increased to 4 mg daily for 16 weeks. Visits are scheduled at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks. Evaluation of primary endpoint occurs at week 24. All subjects receive a phone call from study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barcitinib | Experimental | Drug: BaricitinibAll subjects will initially receive baricitinib 2mg daily for 8 weeks. If no unexpected serious adverse events related to baricitinib have occurred during the first 8 weeks of treatment in the opinion of the investigator, the dose will be increased to 4 mg daily for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or non-pregnant, non-nursing female
- Age ≥18 years at time of consent
- Typical cutaneous DM manifestations including heliotrope rash, Gottron's papules/sign, V-sign, shawl sign, holster sign, confirmed by skin biopsy, with or without DM muscle disease classified based on the Bohan and Peter criteria at screening and baseline visit
- Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score ≥ 12 corresponding to moderate to severe disease activity at screening and baseline visit
- Active disease (i.e., CDASI ≥ 12) despite adequate prior treatment experience with corticosteroids, immunosuppressants, or biologics
Key exclusion criteria (28 listed)
- Previous treatment with baricitinib.
- Previous treatment with tofacitinib or updacitinib.
- Current use of strong Organic Anion Transporters 3 (OAT3) inhibitors including probenecid.
- Uncontrolled or rapidly progressive myositis or interstitial lung disease at the discretion of the investigator which is likely to warrant escalation in therapy beyond permitted background medications.
- Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer).
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 |
|---|---|---|
| BaricitinibAlso: OlumiantThe investigational medicinal product (IP) for this study is baricitinib 2mg. The dose will be administered as one 2mg tablet by mouth once daily for the first 8 weeks of study. If no unexpected serious adverse events related to baricitinib in the opinion of the investigator occur during the first 8 weeks of treatment, the dose will be increased to two 2mg tablets (4mg daily) for the remaining 16 weeks of study. All study participants will take baricitinib in combination with standard of care background therapy. | Drug | Barcitinib |
Primary outcome
Cutaneous Disease Activity Severity Index (CDASI) activity score
Time frame: 24 Weeks
Change in Cutaneous Disease Activity Severity Index (CDASI) activity score (0-100), higher scores mean a worse outcome
5 secondary outcomes
Cutaneous Disease Activity Severity Index (CDASI) activity score
Time frame: 12 weeks
International Myositis Assessment & Clinical Studies Group (IMACS) Disease Activity Core Set Measures
Time frame: 12 weeks and 24 weeks
SF-36
Time frame: 12 weeks and 24 weeks
Dermatology Life Quality Index (DLQI)
Time frame: 12 weeks and 24 weeks
Adverse event
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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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.
Kwanghoon Han, MD principal investigator
University of Washington
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 Baricitinib in people with Dermatomyositis, run by University of Washington 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 28 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: withdrawn, as of the sponsor's last update on 1 Sep 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 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cutaneous Disease Activity Severity Index (CDASI) activity score (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 1 Sep 2023.