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Hashimoto ThyroiditisPhase 2/3COLTHYRNCT07571681

Colchicine for Autoimmune and Subacute Thyroiditis

A Phase 2/3 study testing colchicine, Prednisolone and NSAID in people with Hashimoto Thyroiditis and Subacute Thyroiditis, run by Mansoura University at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Thyroiditis includes inflammatory thyroid disorders such as Hashimoto's thyroiditis and subacute thyroiditis. These conditions may cause thyroid pain, neck tenderness, elevated inflammatory markers, thyroid dysfunction, fatigue, and recurrence. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
colchicine, Prednisolone and NSAID
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesin 2 countries
Study dates
15 Jun 2026to Sep 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 70 years
  • Newly diagnosed Hashimoto's thyroiditis or Subacute thyroiditis
  • Diagnosis confirmed clinically, biochemically, and ultrasonographically
  • Ability to provide written informed consent

Who cannot join

  • Pregnancy or breastfeeding
  • Severe renal impairment
  • Severe hepatic disease
  • Cytopenia
  • Active serious infection
  • Known hypersensitivity to colchicine
Show all 9Show fewer
  • Chronic corticosteroid use within previous 30 days
  • Participation in another interventional trial
  • Any condition affecting safety or protocol adherence

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Amr A. El Sehrawy, MD, PhD, FRCPE contact

+966503845019

amrsehrawy@mans.edu.eg

Amro A. Elbaz, MD contact

+201000191910

dramrbaz@mans.edu.eg

2 sites in 2 countries

Egypt1 site, 1 recruiting

  • Mansoura University

    Al Mansurah, Dakahlia Governorate, 35516

    Gamal I Ahmed, Department Secretary, +20 10 15613189

    Recruiting

Other trials in Egypt

Saudi Arabia1 site, 1 recruiting

  • Saudi German Hospital

    Jeddah, Mecca Region, 21461

    Amani A Amodii, Member, Saudi German Hospital, +966531911630

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Colchicine as a Novel Anti-Inflammatory Strategy in Autoimmune and Subacute Thyroiditis: A Prospective Three-Arm Randomized Controlled Trial

Thyroiditis includes inflammatory thyroid disorders such as Hashimoto's thyroiditis and subacute thyroiditis. These conditions may cause thyroid pain, neck tenderness, elevated inflammatory markers, thyroid dysfunction, fatigue, and recurrence. Current management includes observation, symptomatic treatment, nonsteroidal anti-inflammatory drugs, and corticosteroids. Although corticosteroids may be effective, relapse after tapering and treatment-related adverse effects remain limitations. Colchicine is hypothesized to reduce inflammatory activity and may improve biochemical and clinical recovery. This study will evaluate the efficacy and safety of low-dose colchicine compared with corticosteroid therapy and supportive care in adults with autoimmune or subacute thyroiditis.

Read the detailed description

Thyroiditis represents a heterogeneous group of inflammatory thyroid disorders. Hashimoto's thyroiditis is characterized by chronic autoimmune-mediated thyroid inflammation and progressive thyroid dysfunction. Subacute thyroiditis commonly presents with painful thyroid enlargement, elevated inflammatory markers, transient thyrotoxicosis, and possible later hypothyroidism.

Current treatment strategies include supportive care, nonsteroidal anti-inflammatory drugs, and corticosteroids. While corticosteroids often provide rapid symptomatic benefit, recurrence after withdrawal and steroid-related adverse effects remain clinically relevant concerns.

Colchicine inhibits microtubule polymerization, leukocyte migration, and inflammasome-mediated signaling. These mechanisms may provide potential benefit in thyroid inflammatory disease.

This prospective three-arm randomized controlled trial will compare colchicine, corticosteroid therapy, and supportive care regarding inflammatory improvement, thyroid function recovery, symptom control, recurrence, and tolerability.

Participants will be randomized in a 1:1:1 ratio and followed for six months. Primary outcomes include changes in C-reactive protein, erythrocyte sedimentation rate, and clinical symptom improvement. Secondary outcomes include thyroid function tests, thyroid autoantibodies, ultrasound improvement, recurrence rate, need for rescue corticosteroid therapy, and adverse events.

This study may help identify an effective steroid-sparing therapeutic strategy for inflammatory thyroid disorders.

Being tested
colchicine, Prednisolone, NSAID
Keywords
Colchicine, Prednisolone, Autoimmune Thyroiditis, Inflammation, C-reactive protein, ESR, Thyroid Pain, Randomized Trial
Medical subject headings
Hashimoto Disease, Thyroiditis, Subacute, Thyroiditis, Thyroiditis, Autoimmune, Inflammation

What participants receive

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

  • colchicineDrug

    Colchicine administered orally according to the study dosing protocol. Dose adjustments permitted based on tolerability and safety assessment.

  • PrednisoloneDrug

    Prednisolone administered orally according to the study treatment protocol with dose tapering based on clinical response and safety monitoring.

  • NSAIDDrug

    Non-steroidal anti-inflammatory drugs administered according to standard clinical practice and patient tolerance.

Study groups in NCT07571681
Study groupRoleWhat they receive
ColchicineExperimentalParticipants will receive oral colchicine 0.5 mg twice daily for 12 weeks. Dose reduction to 0.5 mg once daily will be permitted if gastrointestinal intolerance occurs.
Receives: Drug: colchicine
PrednisoloneActive comparatorParticipants will receive oral prednisolone 20 mg daily for 14 days, followed by tapering by 5 mg every 1 to 2 weeks according to clinical response.
Receives: Drug: Prednisolone
Supportive CareActive comparatorParticipants will receive standard supportive care including analgesics, NSAIDs if clinically indicated, hydration advice, and monitoring.
Receives: Drug: NSAID

What is being measured

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

  1. Mean Change in C-Reactive Protein (CRP)

    Reduction in serum C-reactive protein concentration compared with baseline among treatment groups.

    Measured: Baseline, Month 3, Month 6

  2. Mean Change in Erythrocyte Sedimentation Rate (ESR)

    Reduction in erythrocyte sedimentation rate compared with baseline among treatment groups.

    Measured: Baseline, Month 3, Month 6

  3. Mean Change in Thyroid Pain and Inflammatory Symptom from Baseline

    Improvement in thyroid pain, neck tenderness, local discomfort, and inflammatory symptoms will be assessed using a standardized Thyroid Pain and Inflammatory Symptom Score ranging from 0 to 10, where higher scores indicate greater symptom severity and lower scores indicate clinical improvement.

    Measured: Baseline, Month 1, Month 3, Month 6

Secondary outcomes (7)

  1. Mean Change in Serum Thyroid-Stimulating Hormone (TSH) Concentration from Baseline

    Assessment of changes in serum thyroid-stimulating hormone (TSH) concentrations compared with baseline values.

    Measured: Baseline, Month 3, Month 6

  2. Mean Change in Serum Free Triiodothyronine (Free T3) and Free Thyroxine (Free T4) Levels from Baseline

    Assessment of changes in serum free triiodothyronine (Free T3) and free thyroxine (Free T4) concentrations compared with baseline values.

    Measured: Baseline, Month 3, Month 6

  3. Mean Change in Serum Thyroid Peroxidase Antibody (TPOAb) and Thyroglobulin Antibody (TgAb) Levels from Baseline

    Assessment of changes in serum thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb) concentrations to evaluate autoimmune inflammatory activity.

    Measured: Baseline, Month 6

  4. Change in Thyroid Ultrasound Inflammatory Findings from Baseline

    Assessment of changes in thyroid ultrasound characteristics, including gland vascularity, parenchymal heterogeneity, gland enlargement, and inflammatory changes compared with baseline findings.

    Measured: Baseline, Month 6

  5. Recurrence Rate of Thyroiditis

    Number and proportion of participants experiencing clinical or biochemical recurrence of thyroiditis after initial improvement during follow-up.

    Measured: Any recurrence during 6-month follow-up

  6. Need for Rescue Corticosteroid Therapy

    Number and proportion of participants requiring rescue corticosteroid treatment because of persistent symptoms, worsening inflammation, or inadequate clinical response.

    Measured: Throughout 6-month follow-up

  7. Adverse Events / Drug Intolerance

    Frequency, type, and severity of adverse events or treatment intolerance including gastrointestinal symptoms, hepatic dysfunction, renal impairment, cytopenia, or steroid-related adverse effects.

    Measured: Baseline to Month 6

Timeline

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

  1. First posted6 May 2026
  2. Study start15 Jun 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 2027 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized in a 1:1:1 ratio to colchicine, prednisolone, or supportive care. Study groups will be followed in parallel for 6 months to assess inflammatory, clinical, and thyroid function outcomes.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07571681
Sponsor's protocol ID
MU-THY-COL-2026-01
Other IDs
MD-MU-IRB-R.24.11.2879
Acronym
COLTHYR
Status last verified
Jul 2026
First submitted
29 Apr 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the corresponding author, following institutional approval and in accordance with ethical and confidentiality regulations.

Publications

  • Li Y, Hu Y, Zhang Y, Cheng K, Zhang C, Wang J. Advances in Subacute Thyroiditis: Pathogenesis, Diagnosis, and Therapies. FASEB J. 2025 Apr 15;39(7):e70525. doi: 10.1096/fj.202403264R.

    PubMed 40203050

  • Wang L, Zhu X, Xu S, Zhou B, Wu Y, Li Z, Zhao Y, Li S, Cheng F, Zhu L. Hashimoto's thyroiditis: from pathogenesis to clinical management. Front Endocrinol (Lausanne). 2026 Feb 2;17:1729316. doi: 10.3389/fendo.2026.1729316. eCollection 2026.

    PubMed 41704486

  • Wolowiec L, Osiak-Gwiazdowska J, Jasniak A, Mucha W, Wojtaluk M, Czerniecka W, Wolowiec A, Banach J, Grzesk G. Colchicine in Contemporary Pharmacotherapy: Mechanistic Insights and Clinical Horizons. J Clin Med. 2025 Oct 7;14(19):7078. doi: 10.3390/jcm14197078.

    PubMed 41096157

  • Bao RH, et al. Balancing the benefits and risks of colchicine use among patients with coronary heart disease. 2025. Colchicine exerts anti-inflammatory effects through inhibition of microtubule function, suppression of NLRP3 inflammasome activation, and reduction of hs-CRP.

  • Plotz B, et al. New perspectives on the NLRP3 inflammasome: colchicine and suppression of inflammatory pathways in metabolic syndrome-associated diseases. Explor Musculoskeletal Dis. 2025;3:1007104.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing colchicine, Prednisolone and NSAID in people with Hashimoto Thyroiditis and Subacute Thyroiditis, run by Mansoura University at 2 sites in 2 countries.

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 9 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: looking for participants now, as of the sponsor's last update on 29 Jul 2026. 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 Egypt, Saudi Arabia. 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 combined 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.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Amr A. El Sehrawy, MD, PhD, FRCPE (+966503845019, amrsehrawy@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in C-Reactive Protein (CRP) (time frame: Baseline, Month 3, Month 6). The study lists 3 primary outcomes in all. 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 NCT07571681, which also lists 5 linked publications.

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 29 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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