IgA VasculitisPhase 3COLCHIVASNCT04008316
Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis
A Phase 3 study testing Colchicine in people with IgA Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- IgA Vasculitis
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2019to 12 Jan 2022
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and < 85 years
- IgA-V recently diagnosed (< 20 days since skin biopsy) and defined by :
- Histologically proven small vessels vasculitis with IgA deposits IgA Vasculitis
- Purpura and/or involvement of at least one organ among kidney, joint, or intestinal tract
Who cannot join
- Severe renal IgA vasculitis:
- impaired renal function, defined as an eGFR < 60 ml per minute per 1.73 m2 (MDRD or CKD-EPI formula)
- proteinuria/creatinuria> 1g/g
- Uncontrolled blood pressure (Systolic blood pressure > 170 mmHg, diastolic blood pressure > 100 mmHg)
- Severe digestive IgA vasculitis:
- intussusception
Show all 22Show fewer
- massive gastrointestinal haemorrhage (requiring transfusion)
- intestinal ischemia
- perforation
- abdominal pain persisting more than one day (EVA > 5) and unresponsive to standard analgesics (level 1 or 2).
- Prior (< 3 months) immunosuppressive or corticosteroid therapy
- Additional cutaneous, and/or digestive and/or chronic renal diseases.
- HIV and B and C Chronic hepatitis
- Pregnancy or breast feeding or women without sufficient contraception among women of childbearing
- Known allergy or intolerance to study medication or any of its excipients (lactose, saccharose)
- Contraindication to colchicine such as:
- severe hepatic insufficiency
- combination with a macrolide (except spiramycin),
- combination with pristinamycin
- Participation in another interventional trial
- Patient having not signed an informed consent
- Patient without Social Security System Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis
Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Quality of life can be significantly altered by frequent cutaneous relapses. Colchicine, historically used for gout flares, is known to be an " old " low cost drug inducing very few adverse events. This molecule inhibits polymorphonuclear cell-chemotaxis to the site of inflammation explaining colchicine clinical efficacy in diseases such as Familial Mediterranean Fever or Behçet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude.
Read the detailed description
Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Quality of life can be significantly altered by frequent cutaneous relapses. Colchicine, historically used for gout flares, is known to be an " old " low cost drug inducing very few adverse events. It inhibits polymorphonuclear cell-chemotaxis to the site of inflammation explaining colchicine clinical efficacy in diseases such as Familial Mediterranean Fever or Behçet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude To assess efficacy of colchicine in adult's cutaneous IgA-V, the investigators conduct a prospective, controlled, double blind, randomized clinical trial, national, multicenter and multidisciplinary (internal medicine, nephrology and dermatology): colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up. The primary objective is to evaluate efficacy of colchicine versus placebo to prevent cutaneous relapses, 6 months after inclusion, in adult patients with cutaneous IgA vasculitis alone or associated with non-severe digestive or renal involvement.
- Conditions
- IgA Vasculitis
- Being tested
- Colchicine
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
colchicine 1mg/day
| Study group | Role | What they receive |
|---|---|---|
| colchicine 1mg/day | Experimental | Colchicine per os: 1 tablet (1mg) / day during 6 months Receives: Drug: Colchicine |
| placebo | Placebo comparator | placebo 1 tablet / day during 6 months Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of the first cutaneous skin relapse
Cutaneous skin relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start12 Nov 2019
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Why it stopped: Sponser decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA VasculitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evangeline PILLEBOUT, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008316
- Sponsor's protocol ID
- P170910J
- Other IDs
- 2018-002114-13, 2018
- Acronym
- COLCHIVAS
- Status last verified
- Nov 2026
- First submitted
- 2 Jul 2019
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Colchicine to Prevent Skin Relapses in Adult's IgA Vasculitis
- ClinicalTrials.gov ID
- NCT04008316
- Acronym / sponsor ID
- COLCHIVAS / P170910J
- Conditions
- IgA Vasculitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponser decision
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 5 Jul 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.
Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Quality of life can be significantly altered by frequent cutaneous relapses. Colchicine, historically used for gout flares, is known to be an " old " low cost drug inducing very few adverse events. This molecule inhibits polymorphonuclear cell-chemotaxis to the site of inflammation explaining colchicine clinical efficacy in diseases such as Familial Mediterranean Fever or Behçet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude.
Detailed description
Immunoglobulin A vasculitis (IgA-V), formerly called Henoch-Schönlein purpura, is an immune vasculitis. Relapses are frequent (30%) and most of the time cutaneous (90%). Cutaneous involvement in adults is more severe (haemorrhagic blister or necrotic skin lesions) and more extensive than in children. Quality of life can be significantly altered by frequent cutaneous relapses. Colchicine, historically used for gout flares, is known to be an " old " low cost drug inducing very few adverse events. It inhibits polymorphonuclear cell-chemotaxis to the site of inflammation explaining colchicine clinical efficacy in diseases such as Familial Mediterranean Fever or Behçet disease. Efficacy of colchicine has also been reported in cutaneous leukocytoclastic vasculitis including IgA-V, but without clinical studies supporting this attitude To assess efficacy of colchicine in adult's cutaneous IgA-V, the investigators conduct a prospective, controlled, double blind, randomized clinical trial, national, multicenter and multidisciplinary (internal medicine, nephrology and dermatology): colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up. The primary objective is to evaluate efficacy of colchicine versus placebo to prevent cutaneous relapses, 6 months after inclusion, in adult patients with cutaneous IgA vasculitis alone or associated with non-severe digestive or renal involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- prospective, controlled, double blind, randomized clinical trial: colchicine 1mg/day versus placebo for 6 months, with a 12 months total follow-up.
| Arm | Type | Receives |
|---|---|---|
| colchicine 1mg/day | Experimental | Drug: ColchicineColchicine per os: 1 tablet (1mg) / day during 6 months |
| placebo | Placebo comparator | Drug: Colchicineplacebo 1 tablet / day during 6 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and < 85 years
- IgA-V recently diagnosed (< 20 days since skin biopsy) and defined by :
Key exclusion criteria (22 listed)
- Severe renal IgA vasculitis:
- Severe digestive IgA vasculitis:
- Prior (< 3 months) immunosuppressive or corticosteroid therapy
- Additional cutaneous, and/or digestive and/or chronic renal diseases.
- HIV and B and C Chronic hepatitis
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 |
|---|---|---|
| Colchicinecolchicine 1mg/day | Drug | colchicine 1mg/day, placebo |
Primary outcome
the occurrence of the first cutaneous skin relapse
Time frame: 6 months
Cutaneous skin relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.
Results and safety
The study was stopped early (reason given: Sponser decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- 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.
Evangeline PILLEBOUT, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with IgA Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 22 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: stopped early, as of the sponsor's last update on 6 Nov 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: Sponser decision). 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?
the occurrence of the first cutaneous skin relapse (time frame: 6 months). 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 6 Nov 2026.