Erythema Nodosum LeprosumPhase 2NCT03807362
CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum
A Phase 2 study testing CC-11050 in people with Erythema Nodosum Leprosum and Leprosy, run by The Leprosy Mission Nepal at 2 sites in Nepal.
Trial summary
This study will be a single center, Phase 2, open-label trial to evaluate the safety and efficacy of 200mg CC-11050 administered twice daily taken with food for patients with moderate to severe ENL. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erythema Nodosum Leprosum, Leprosy
- What is being tested?
- CC-11050
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesNepal
- Study dates
- 7 Jan 2018to 31 Dec 2024
- 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
- Study participants must satisfy the following criteria to be enrolled in the study:
- Must be 18 -65 years old, weight > 35kg for women and >40kg for men at the time of signing the informed consent.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Have signs or symptoms of new or new episode ENL. In Step one, participants must be male. In Step 2, participants can be either male or female.
- Able to adhere to the study schedule and other protocol requirements.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
- Patients on continuous rifampicin will be excluded, however, If rifampicin is given only once a month as part of a multi-drug regimen, a minimum of 2-week washout period is required prior to administration of CC-11050
- Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study.
- Any condition that confounds the ability to interpret data from the study (ie, HIV, chronic HepB, chronic HepC or TB patients under active treatment). Resolved TB patients will not be excluded from the study.
- Stable and well managed patients with Diabetes and hypertension will not be excluded from the study.
- Use of systemic corticosteroid or immunosuppressant therapy within 7 days of study medication initiation
- Pregnant or nursing females.
Trial locations and contacts
2 sites in 1 country.
Indra B Napit, MD contact
Nepal2 sites, 2 recruiting
- Not yet recruiting
The Leprosy Mission Nepal
Kathmandu, Bagmati, 44700
Mahesh Shah, MD, drmahesh_shah@yahoo.com
iIndra B Napit, MD, indran@tlmnepal.org
- Recruiting
Anandaban Hospital
Lalitpur, Bagmati, 44700
Indra B Napit, MD, +9779851136027, indran@tlmnepal.org
Mahesh Shah, MD, +9779841203417, drmahesh_shah@yahoo.com
About this study
Official title: A Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of CC-11050 in Nepalese Patients With Erythema Nodosum Leprosum
This study will be a single center, Phase 2, open-label trial to evaluate the safety and efficacy of 200mg CC-11050 administered twice daily taken with food for patients with moderate to severe ENL. The study will be performed in two steps: 1) to evaluate immediate effect in safety and efficacy of drug in 10 males with new or new recurrent episode ENL and, if found to be safe and effective by the DSMB and 2) if allowed by the DSMB, and approved by relevant study stakeholders, an additional 40 ENL patients will be enrolled for up to 52 weeks of treatment. A safety analysis will be conducted on all patients who have received at least one dose of study drug, and will include the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation.
- Conditions
- Erythema Nodosum Leprosum, Leprosy
- Being tested
- CC-11050
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-11050Drug
CC-11050 is a novel anti-inflammatory compound with potential to treat a variety of chronic inflammatory conditions.
| Study group | Role | What they receive |
|---|---|---|
| CC-11050 treatment | Experimental | 200mg CC-11050 will be administered twice daily as a pill taken with food (at breakfast and evening meal) for participants with moderate to severe ENL for 10 days, then up to 28 days (during Step 1) and then up to 1 year (during Step 2). Receives: Drug: CC-11050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with moderate to severe ENL with severity changes as assessed by the ENL Severity Scale.
Changes in ENL Severity Scale Score (Walker et al., PLoS Negl Trop Dis 11(7): e0005716, https://doi.org/10.1371/journal.pntd.0005716) as compared to baseline and any previous time points. Ten clinical categories contribute 0-3 points toward the total score of 0-30. An ENL patient with a total scale score of less than 9 is considered to have mild ENL, while scores >9 are considered moderate to severe ENL. A minimum score of 9 is required to indicate sufficient ENL symptoms from which post-intervention reduction in score(s) can be determined meaningful improvement.
Measured: 10 days, 28 days and monthly up to 1 year of treatment
Secondary outcomes (8)
Number of participants with moderate to severe ENL with decreased duration of episode(s) as assessed by standard ENL episode definition.
Changes in ENL episode duration(s) as compared to baseline and any previous time points. By definition, if ENL symptoms are separated by time and no need of treatment for >28 days, they are considered separate episodes. Recurrence is anytime another episode occurs after >28 days of no prior treatment or symptoms.
Measured: 10 days, 28 days, monthly up to 1 year of treatment and up to 1 year followup after treatment cessation.
Number of participants with moderate to severe ENL with decreased bacterial index (BI) as assessed by slit skin smear microscopy.
Changes in slit skin smear microscopy BI as compared to baseline. BI can range from 0-6.
Measured: Enrolment and after 1 year treatment.
Number of participants with moderate to severe ENL with decreased bacterial index (BI) as assessed skin histopathology.
Changes in skin histopathology bacterial index (BI) as compared to baseline. BI can range from 0-6.
Measured: Enrolment and after 1 year treatment.
Number of patients with moderate to severe ENL with improved peripheral neuropathy as assessed by standardized monofilament and voluntary muscle tests.
Changes in scores for peripheral neuropathy as indicated by monofilament and voluntary muscle tests compared from baseline and any previous time points. To check neuropathy, 7 motor function nerves and 6 sensory function nerves on each side of the body are assessed for a total 26 nerves. Each are assessed on 3 sites using a standard set of Semmes-Weinstein monofilaments. The 200mg filament and the 2g filament represent threshold for the hand and foot, respectively. The 0-5 Medical Research Council (MRC) scale is used for motor function assessment. Sensory scores >3 and motor nerve scoring (MRC) < 5 are regarded impaired (indicating neuropathy). More method specifics can be found here: van Veen N.H., et al., Corticosteroids for treating nerve damage in leprosy. Cochrane Database Syst Rev, 2007(2): p. CD005491.
Measured: enrolment, 10 days, 28 days, biweekly (as needed), up to 1 year treatment, up to 1 year followup after treatment cessation
Number of participants with moderate to severe ENL with improved quality of life as assessed by the World Health Organization Quality of Life tool.
Changes in scores for the World Health Organization Quality of Life assessment as compared to baseline and any previous time points. There are 26 questions in this questionnaire and each can be scored from 1 to 5 points. The highest possible score is 130 and lowest possible score is 26. A higher score denotes better quality of life.
Measured: Enrolment, 28 days, monthly up to 1 year of treatment and up to 1 year followup after treatment cessation.
Number of participants with moderate to severe ENL as assessed by standard blood panel and basic metabolic testing.
Abnormalities or change in values in comparison to baseline and any previous time points.
Measured: Enrolment, day 10, day 17, day 28, monthly up to 1 year of treatment, and 1 month post-cessation of treatment.
Number of participants with moderate to severe ENL as assessed by urinalysis.
Detection of albumin (qualitative) as compared to baseline and any previous time points. Urine albumin is related to ENL severity and kidney function test.
Measured: Enrolment, day 10, day 17, day 28, monthly up to 1 year of treatment, and 1 month post-cessation of treatment.
Number of participants with moderate to severe ENL as assessed by serological indicators associated with ENL.
Detection of rheumatoid arthritis factor (positive) and/or C-reactive protein (positive) as compared to baseline and any previous time points.
Measured: Enrolment, day 10, day 17, day 28, monthly up to 1 year of treatment, and 1 month post-cessation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start7 Jan 2018
- Primary completion30 Mar 2021 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erythema Nodosum LeprosumStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single center, open label pilot study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leprosy Mission Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahesh Shah, MD, Principal investigator, The Leprosy Mission Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807362
- Sponsor's protocol ID
- Nepal CC-11050
- Status last verified
- Jul 2020
- First submitted
- 14 Sep 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shah M, Rana DR, Neupane KD, Maharjan P, Baral S, Shrestha R, Shakya J, Aryal B, Acharya B, Napit IB, Hagge DA. Dovramilast for Erythema Nodosum Leprosum in Patients With Leprosy in Nepal: Protocol for a Phase 2 Open-Label Pilot Study. JMIR Res Protoc. 2026 Jun 17;15:e88069. doi: 10.2196/88069.
PubMed 42308518
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label Pilot Study to Evaluate the Safety and Efficacy of CC-11050 in Nepalese Patients With Erythema Nodosum Leprosum
- ClinicalTrials.gov ID
- NCT03807362
- Acronym / sponsor ID
- Nepal CC-11050
- Conditions
- Erythema Nodosum Leprosum, Leprosy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Leprosy Mission NepalUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Jan 2019 (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 will be a single center, Phase 2, open-label trial to evaluate the safety and efficacy of 200mg CC-11050 administered twice daily taken with food for patients with moderate to severe ENL. The study will be performed in two steps: 1) to evaluate immediate effect in safety and efficacy of drug in 10 males with new or new recurrent episode ENL and, if found to be safe and effective by the DSMB and 2) if allowed by the DSMB, and approved by relevant study stakeholders, an additional 40 ENL patients will be enrolled for up to 52 weeks of treatment. A safety analysis will be conducted on all patients who have received at least one dose of study drug, and will include the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single center, open label pilot study
| Arm | Type | Receives |
|---|---|---|
| CC-11050 treatment | Experimental | Drug: CC-11050200mg CC-11050 will be administered twice daily as a pill taken with food (at breakfast and evening meal) for participants with moderate to severe ENL for 10 days, then up to 28 days (during Step 1) and then up to 1 year (during Step 2). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be 18 -65 years old, weight > 35kg for women and >40kg for men at the time of signing the informed consent.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Have signs or symptoms of new or new episode ENL. In Step one, participants must be male. In Step 2, participants can be either male or female.
- Able to adhere to the study schedule and other protocol requirements.
Key exclusion criteria (8 listed)
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study.
- Patients on continuous rifampicin will be excluded, however, If rifampicin is given only once a month as part of a multi-drug regimen, a minimum of 2-week washout period is required prior to administration of CC-11050
- Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study.
- Any condition that confounds the ability to interpret data from the study (ie, HIV, chronic HepB, chronic HepC or TB patients under active treatment). Resolved TB patients will not be excluded from the study.
- Stable and well managed patients with Diabetes and hypertension will not be excluded from the study.
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 |
|---|---|---|
| CC-11050CC-11050 is a novel anti-inflammatory compound with potential to treat a variety of chronic inflammatory conditions. | Drug | CC-11050 treatment |
Primary outcome
Number of participants with moderate to severe ENL with severity changes as assessed by the ENL Severity Scale.
Time frame: 10 days, 28 days and monthly up to 1 year of treatment
Changes in ENL Severity Scale Score (Walker et al., PLoS Negl Trop Dis 11(7): e0005716, https://doi.org/10.1371/journal.pntd.0005716) as compared to baseline and any previous time points. Ten clinical categories contribute 0-3 points toward the total score of 0-30. An ENL patient with a total scale score of less than 9 is considered to have mild ENL, while scores >9 are considered moderate to severe ENL. A minimum score of 9 is required to indicate sufficient ENL symptoms from which post-intervention reduction in score(s) can be determined meaningful improvement.
8 secondary outcomes
Number of participants with moderate to severe ENL with decreased duration of episode(s) as assessed by standard ENL episode definition.
Time frame: 10 days, 28 days, monthly up to 1 year of treatment and up to 1 year followup after treatment cessation.
Number of participants with moderate to severe ENL with decreased bacterial index (BI) as assessed by slit skin smear microscopy.
Time frame: Enrolment and after 1 year treatment.
Number of participants with moderate to severe ENL with decreased bacterial index (BI) as assessed skin histopathology.
Time frame: Enrolment and after 1 year treatment.
Number of patients with moderate to severe ENL with improved peripheral neuropathy as assessed by standardized monofilament and voluntary muscle tests.
Time frame: enrolment, 10 days, 28 days, biweekly (as needed), up to 1 year treatment, up to 1 year followup after treatment cessation
Number of participants with moderate to severe ENL with improved quality of life as assessed by the World Health Organization Quality of Life tool.
Time frame: Enrolment, 28 days, monthly up to 1 year of treatment and up to 1 year followup after treatment cessation.
Number of participants with moderate to severe ENL as assessed by standard blood panel and basic metabolic testing.
Time frame: Enrolment, day 10, day 17, day 28, monthly up to 1 year of treatment, and 1 month post-cessation of treatment.
Number of participants with moderate to severe ENL as assessed by urinalysis.
Time frame: Enrolment, day 10, day 17, day 28, monthly up to 1 year of treatment, and 1 month post-cessation of treatment.
Number of participants with moderate to severe ENL as assessed by serological indicators associated with ENL.
Time frame: Enrolment, day 10, day 17, day 28, monthly up to 1 year of treatment, and 1 month post-cessation of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 42308518Shah M, Rana DR, Neupane KD, Maharjan P, Baral S, Shrestha R, Shakya J, Aryal B, Acharya B, Napit IB, Hagge DA. Dovramilast for Erythema Nodosum Leprosum in Patients With Leprosy in Nepal: Protocol for a Phase 2 Open-Label Pilot Study. JMIR Res Protoc. 2026 Jun 17;15:e88069. doi: 10.2196/88069.
- Individual participant dataSharing planned: Undecided
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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.
Indra B Napit, MD contact
Mahesh Shah, MD principal investigator
The Leprosy Mission Nepal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-11050 in people with Erythema Nodosum Leprosum and Leprosy, run by The Leprosy Mission Nepal at 2 sites in Nepal.
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 5 inclusion and 8 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. 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 Mahesh Shah, MD (+9779841203417, drmahesh_shah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with moderate to severe ENL with severity changes as assessed by the ENL Severity Scale. (time frame: 10 days, 28 days and monthly up to 1 year of treatment). 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 NCT03807362, 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 7 Jul 2020.